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1. Development of a new model of insulin sensitivity in patients with type 2 diabetes and association with mortality

Author

Ciardullo, S, Dodesini, A, Lepore, G, Corsi, A, Scaranna, C, Perseghin, G, Trevisan, R, Ciardullo, Stefano, Dodesini, Alessandro Roberto, Lepore, Giuseppe, Corsi, Anna, Scaranna, Cristiana, Perseghin, Gianluca, Trevisan, Roberto, Ciardullo, S, Dodesini, A, Lepore, G, Corsi, A, Scaranna, C, Perseghin, G, Trevisan, R, Ciardullo, Stefano, Dodesini, Alessandro Roberto, Lepore, Giuseppe, Corsi, Anna, Scaranna, Cristiana, Perseghin, Gianluca, and Trevisan, Roberto

Abstract

CONTEXT: Despite being one of the major drivers of diabetes incidence, the degree of insulin resistance in patients with type 2 diabetes (T2D) is not usually evaluated in clinical practice or in large epidemiologic studies. OBJECTIVE: To identify a model of insulin sensitivity using widely available clinical and laboratory parameters in patients with T2D and evaluate its association with all-cause and cardiovascular mortality. METHODS: One hundred forty patients with T2D underwent a euglycemic hyperinsulinemic clamp to measure total body glucose disposal rate (mg kg-1 minute-1). We used demographic, clinical, and common laboratory parameters to estimate insulin sensitivity (IS) via stepwise linear regression on 85 patients (training cohort) and validated it in the remaining 55 (validation cohort). The identified equation was then applied to 3553 patients with T2D from the 1999-2010 cycles of the National Health and Nutrition Examination Survey (NHANES) to evaluate its association with all-cause and cardiovascular mortality up to December 2015. RESULTS: The best model included triglycerides, gamma glutamyl transpeptidase, albumin excretion rate, and body mass index. The identified IS score correlated well with the clamp-derived glucose disposal rate in both the training (r = 0.77, P < .001) and the validation (r = 0.74, P < .001) cohorts. In the NHANES cohort, after a median follow-up of 8.3 years, 1054 patients died, 265 of cardiovascular causes. In a multivariable Cox proportional hazard model adjusted for age, sex, race-ethnicity, education, cigarette smoke, total cholesterol, chronic kidney disease, blood pressure, prevalent cardiovascular disease, and alcohol consumption, a higher estimated IS was associated with a lower risk of both all-cause and cardiovascular mortality. CONCLUSION: We propose a new model of IS in patients with T2D based on readily available clinical and laboratory data. Its potential applications are in both diagnosis as well as prognos

Published
2024

2. Advanced Hybrid Closed-Loop System Achieves and Maintains Recommended Time in Range Levels for Up To 2 Years: Predictors of Best Efficacy

Author

Lepore, G, Borella, N, Castagna, G, Ippolito, S, Bonfadini, S, Corsi, A, Scaranna, C, Dodesini, A, Bellante, R, Trevisan, R, Lepore, Giuseppe, Borella, Nicolò Diego, Castagna, Giona, Ippolito, Silvia, Bonfadini, Silvia, Corsi, Anna, Scaranna, Cristiana, Dodesini, Alessandro Roberto, Bellante, Rosalia, Trevisan, Roberto, Lepore, G, Borella, N, Castagna, G, Ippolito, S, Bonfadini, S, Corsi, A, Scaranna, C, Dodesini, A, Bellante, R, Trevisan, R, Lepore, Giuseppe, Borella, Nicolò Diego, Castagna, Giona, Ippolito, Silvia, Bonfadini, Silvia, Corsi, Anna, Scaranna, Cristiana, Dodesini, Alessandro Roberto, Bellante, Rosalia, and Trevisan, Roberto

Abstract

Aim: To evaluate the long-term efficacy, up to 2 years, of an advanced hybrid closed-loop (AHCL) system and to assess predictors of best results of the therapy. Methods: We retrospectively evaluated 296 adults with type 1 diabetes mellitus [mean age 42.8 - 16.5 years, men 42.9%, duration of diabetes 22.5 - 12.8 years, body mass index 24.9 - 4.7 kg/m2, baseline glycated hemoglobin (HbA1c) 63.4 - 12.2 mmol/mol (8.0 - 1.1%) ] who used the MiniMed_ 780G system. Demographic and clinical data were recorded. Continuous glucose monitoring (CGM)-derived metrics and insulin requirement were analyzed from the 4 weeks before and from every quarter after the switch to the AHCL system. Results: In the first quarter of AHCL treatment, all CGM metrics improved. Time in range (TIR) increased from 58.1 - 17.5% to 70.3 - 9.5% (P < 0.0001). The improvement lasted for up to 2 years of observation regardless of previous insulin therapies. Throughout the period of observation, 53.4% of participants achieved mean TIR >70%, 92.6% mean time below range <4%, and 46% mean glucose management indicator [removed]70%. At multivariable analysis, lower HbA1c remained independently associated with a better glycemic control. However, mean TIR increased more in participants with a higher baseline HbA1c. Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to 24 months along with a low risk for hypoglycemia, confirming the safety of the system. Lower baseline HbA1c was the main predictor of better efficacy of therapy, although higher baseline HbA1c was associated with the greatest improvement in mean TIR.

Published
2024

3. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Mammì, F., Bruzzese, M., Schettino, M., Nuzzo, M.G., Di Blasi, V., Fresa, R., Lambiase, C., Iafusco, D., Zanfardino, A., Confetto, S., Bozzetto, L., Annuzzi, G., Alderisio, A., Riccardi, G., Gentile, S., Marino, G., Guarino, G., Zucchini, S., Maltoni, G., Suprani, T., Graziani, V., Nizzoli, M., Acquati, S., Cavani, R., Romano, S., Michelini, M., Manicardi, E., Bonadonna, R., Dei Cas, A., Dall'aglio, E., Papi, M., Riboni, S., Manicardi, V., Pugni, V., Lasagni, A., Street, M.E., Pagliani, U., Rossi, C., Assaloni, R., Brunato, B., Tortul, C., Zanette, G., Li Volsi, P., Zanatta, M., Tonutti, L., Agus, S., Pellegrini, M.A., Ceccano, P., Pozzilli, G., Anguissola, Beretta, Buzzetti, R., Moretti C, C., Leto, G., Pozzilli, P., Manfrini, S., Maurizi, A.R., Leotta, S., Altomare, M., Abbruzzese, S., Carletti, S., Suraci, C., Filetti, S., Manca Bitti, M.L., Arcano, S., Cavallo, M.G., De Bernardinis, M., Pitocco, D., Caputo, S., Rizzi, A., Manto, A., Schiaffini, R., Cappa, M., Benevento, D., Frontoni, S., Malandrucco, I., Morano, S., Filardi, T., Lauro, D., Marini, M.A., Castaldo, E., Sabato, D., Tuccinardi, F., Forte, E., Viterbori, P., Arnaldi, C., Minuto, N., d'Annunzio, G., Corsi, A., Rota, R., Scaranna, C., Trevisan, R., Valentini, U., Girelli, A., Bonfadini, S., Zarra, E., Plebani, A., Prandi, E., Felappi, B., Rocca, A., Meneghini, E., Galli, P., Ruggeri, P., Carrai, E., Fugazza, L., Baggi, V., Conti, D., Bosi, E., Laurenzi, A., Caretto, A., Molinari, C., Orsi, E., Grancini, V., Resi, V., Bonfanti, R., Favalli, V., Bonura, C., Rigamonti, A., Bonomo, M., Bertuzzi, F., Pintaudi, B., Disoteo, O., Perseghin, G., Perra, S., Chiovato, L., De Cata, P., Zerbini, F., Lovati, E., Laneri, M., Guerraggio, L., Bossi, A.C., De Mori, V., Galetta, M., Meloncelli, I., Aiello A, A., Di Vincenzo, S., Nuzzi, A., Fraticelli, E., Ansaldi, E., Battezzati, M., Lombardi, M., Balbo, M., Lera, R., Secco, A., De Donno, V., Cadario, F., Savastio, S., Ponzani, C., Aimaretti, G., Rabbone, I., Ignaccolo, G., Tinti, D., Cerutti, F., Bari, F., Giorgino, F., Piccinno, E., Zecchino, O., Cignarelli, M., Lamacchia, O., Picca, G., De Cosmo, S., Rauseo, A., Tomaselli, L., Tumminia, A., Egiziano, C., Scarpitta, A.M., Maggio, F., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Scorsone, A., Scatena, A., Gregori, G., Lucchesi, S., Gadducci, F., Di Cianni, S., Pancani, S., Del Prato, S., Aragona, M., Crisci, I., Calianno, A., Fattor, B., Crazzolara, D., Reinstadler, P., Longhi, S., Incelli, G., Rauch, S., Romanelli, T., Orrasch, M., Cauvin, V., Franceschi, R., Lalli, C., Pianta, A., Marangoni, A., Aricò, C.N., Marin, N., Nogara, N., Simioni, N., Filippi, A., Gidoni Guarneri, G.L., Contin M.L, M.L., Decata, A.P., Bondesan, L., Confortin, L., Coracina, A., Lombardi, S., Costa Padova, S., Cipponeri, E., Scotton, R., Galasso, S., Boscari, F., Zanon, M.S., Vinci, C., Lisato, G., Gottardo, L., Bonora, E., Trombetta, M., Negri, C., Brangani, C., Maffeis, C., Sabbion, A., Marigliano, M., Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Laviola, Luigi, Rabbone, Ivana, Schiaffini, Riccardo, and Bruttomesso, Daniela

Published
2018
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4. Sex differences in food choices, adherence to dietary recommendations and plasma lipid profile in type 2 diabetes – The TOSCA.IT study

Author

Vitale, M., Masulli, M., Cocozza, S., Anichini, R., Babini, A.C., Boemi, M., Bonora, E., Buzzetti, R., Carpinteri, R., Caselli, C., Ceccarelli, E., Cignarelli, M., Citro, G., Clemente, G., Consoli, A., Corsi, L., De Gregorio, A., Di Bartolo, P., Di Cianni, G., Fontana, L., Garofolo, M., Giorda, C.B., Giordano, C., Grioni, S., Iovine, C., Longhitano, S., Mancastroppa, G., Mazzucchelli, C., Montani, V., Mori, M., Perriello, G., Rinaldi, M.E., Ruffo, M.C., Salvi, L., Sartore, G., Scaranna, C., Tonutti, L., Zamboni, C., Zogheri, A., Krogh, V., Cappellini, F., Signorini, S., Riccardi, G., and Vaccaro, O.

Published
2016
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5. IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Author

Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, Bonora, B, Fadini G. P., Buzzetti R., Fittipaldi M. R., D'Incau F., Da Porto A., Girelli A., Simoni L., Lastoria G., Consoli A., Iazzetta N., Di Giovanni G., Carbonara O., Aragiusto C., Carleo D., Da Rosa N., Martedi E., Landolfi L., Marracino M., Tortora A., De Morelli G., Casarsa V., Maddaloni E., Siena A., Pitocco D., Tartaglione L., Rizzi A., Leonetti F., Fasolo M., Morsello G., Bulzomi R., Ruga G., Bianconi A., Torre E., Rebora A., Cecoli F., Monti E., Bonfadini S., Dotti S., Madaschi S., Trevisan R., Albizzi M., Bellante R., Corsi A., Scaranna C., De Cata P., Liboa F., Ghilotti S., Tortato E., Lanari L., Turchi F., Gabellieri E., Lamacchia O., Colucci C., Mileti G., Coluzzi S., Carrieri F., Rossetti P., Anzaldi M., Di Benedetto A., Ruggeri D., Scatena A., Ranchelli A., Ragusa I., Gregori G., Crisci I., Mori M., Baccetti F., Anichini R., Salutini E., Vinci C., Colletti I., Zanon M. S., Altomari A., Bonora B. M., Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, Bonora, B, Fadini G. P., Buzzetti R., Fittipaldi M. R., D'Incau F., Da Porto A., Girelli A., Simoni L., Lastoria G., Consoli A., Iazzetta N., Di Giovanni G., Carbonara O., Aragiusto C., Carleo D., Da Rosa N., Martedi E., Landolfi L., Marracino M., Tortora A., De Morelli G., Casarsa V., Maddaloni E., Siena A., Pitocco D., Tartaglione L., Rizzi A., Leonetti F., Fasolo M., Morsello G., Bulzomi R., Ruga G., Bianconi A., Torre E., Rebora A., Cecoli F., Monti E., Bonfadini S., Dotti S., Madaschi S., Trevisan R., Albizzi M., Bellante R., Corsi A., Scaranna C., De Cata P., Liboa F., Ghilotti S., Tortato E., Lanari L., Turchi F., Gabellieri E., Lamacchia O., Colucci C., Mileti G., Coluzzi S., Carrieri F., Rossetti P., Anzaldi M., Di Benedetto A., Ruggeri D., Scatena A., Ranchelli A., Ragusa I., Gregori G., Crisci I., Mori M., Baccetti F., Anichini R., Salutini E., Vinci C., Colletti I., Zanon M. S., Altomari A., and Bonora B. M.

Abstract

Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

Published
2022

6. Real-World Insulin Treatment in Pregnant Women with Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System

Author

Dodesini, A, Borella, N, Lepore, G, Corsi, A, Bonfadini, S, Bellante, R, Scaranna, C, Trevisan, R, Dodesini, Alessandro Roberto, Borella, Nicolò Diego, Lepore, Giuseppe, Corsi, Anna, Bonfadini, Silvia, Bellante, Rosalia, Scaranna, Cristiana, Trevisan, Roberto, Dodesini, A, Borella, N, Lepore, G, Corsi, A, Bonfadini, S, Bellante, R, Scaranna, C, Trevisan, R, Dodesini, Alessandro Roberto, Borella, Nicolò Diego, Lepore, Giuseppe, Corsi, Anna, Bonfadini, Silvia, Bellante, Rosalia, Scaranna, Cristiana, and Trevisan, Roberto

Published
2023

7. IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Author

Fadini, G. P., Buzzetti, R., Fittipaldi, M. R., D'Incau, F., Da Porto, A., Girelli, A., Simoni, L., Lastoria, G., Consoli, A., Iazzetta, N., Di Giovanni, G., Carbonara, O., Aragiusto, C., Carleo, D., Da Rosa, N., Martedi, E., Landolfi, L., Marracino, M., Tortora, Annalisa, De Morelli, G., Casarsa, V., Maddaloni, E., Siena, Annunziata, Pitocco, Dario, Tartaglione, Linda, Rizzi, A., Leonetti, F., Fasolo, M., Morsello, G., Bulzomi, R., Ruga, G., Bianconi, A., Torre, Enza, Rebora, A., Cecoli, F., Monti, E., Bonfadini, S., Dotti, S., Madaschi, S., Trevisan, R., Albizzi, M., Bellante, R., Corsi, Alessandro, Scaranna, C., De Cata, P., Liboa, F., Ghilotti, S., Tortato, E., Lanari, L., Turchi, F., Gabellieri, E., Lamacchia, O., Colucci, C., Mileti, G., Coluzzi, Simone, Carrieri, F., Rossetti, P., Anzaldi, Mauro, Di Benedetto, A., Ruggeri, D., Scatena, A., Ranchelli, A., Ragusa, I., Gregori, G., Crisci, I., Mori, Marco Ernesto, Baccetti, F., Anichini, R., Salutini, E., Vinci, C., Colletti, I., Zanon, M. S., Altomari, A., Bonora, B. M., Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, and Bonora, B

Subjects
Type&nbsp, Real-world evidence, Endocrinology, Diabetes and Metabolism, IDegLira, Basal bolus therapy (BB), Basal insulin analogue, Basal oral therapy (BOT), Glycated hemoglobin (HbA1c), Oral antidiabetic drugs (OADs), Rapid insulin analogue, Type 2 diabetes, Settore MED/13 - ENDOCRINOLOGIA, Type 2 diabete, Type 2 diabetes, Internal Medicine, 2 diabetes
Abstract

Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

Published
2022

8. Switching to the MinimedTM 780G system achieves clinical targets for CGM in adults with type 1 diabetes regardless of previous insulin strategy and baseline glucose control

Author

Lepore, G, Rossini, A, Bellante, R, Corsi, A, Scaranna, C, Dodesini, A, Trevisan, R, Lepore, Giuseppe, Rossini, Alessandro, Bellante, Rosalia, Corsi, Anna, Scaranna, Cristiana, Dodesini, Alessandro Roberto, Trevisan, Roberto, Lepore, G, Rossini, A, Bellante, R, Corsi, A, Scaranna, C, Dodesini, A, Trevisan, R, Lepore, Giuseppe, Rossini, Alessandro, Bellante, Rosalia, Corsi, Anna, Scaranna, Cristiana, Dodesini, Alessandro Roberto, and Trevisan, Roberto

Abstract

Aims: Advanced hybrid closed-loop (AHCL) systems represent the latest introduction in the treatment of type 1 diabetes (T1DM). Randomized controlled trials and real-world evidence studies showed that AHCL systems are a safe and effective insulin management strategy. Aim of this retrospective, single-center, real-life study was to evaluate the effect on metabolic control, evaluated by continuous glucose monitoring (CGM) metrics, of the switch from four available insulin strategies to an AHCL system in adult patients with type 1 diabetes. Methods: A total of 102 patients with T1DM (mean age 42.1 ± 16.3 years, males/females 47/55, duration of diabetes 21.4 ± 13.3 years, BMI 24.4 ± 4.5 kg/m2, HbA1c 59.9 ± 9.6 mmol/mol or 7.6 ± 0.9%), treated with four different insulin therapies [multiple daily insulin (MDI) therapy, continuous subcutaneous insulin infusion (CSII), sensor-augmented pump (SAP) with predictive low-glucose suspend (PLGS), and hybrid closed loop (HCL) system] were evaluated before hand, two months and six months after switching to an AHCL (MinimedTM 780G system, Medtronic, Northridge, CA) system. Results: Two months after the switch, mean GCM metrics improved in all four treatment groups. Six months after the switch, the participants of all four groups achieved a mean GMI < 53 mmol/mol, TIR > 70%, TBR < 4%, and CV < 36%, which is recommended by the ADA Standard of Medical Care in Diabetes 2022, including the MDI group with worse baseline glycemic control. Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to six months independently of previous insulin treatment and baseline conditions.

Published
2022

9. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case-Control Study

Author

Lepore, G, Scaranna, C, Corsi, A, Dodesini, A, Trevisan, R, Lepore G., Scaranna C., Corsi A., Dodesini A. R., Trevisan R., Lepore, G, Scaranna, C, Corsi, A, Dodesini, A, Trevisan, R, Lepore G., Scaranna C., Corsi A., Dodesini A. R., and Trevisan R.

Abstract

There are no data whether hybrid closed-loop (HCL) systems are superior to sensor-augmented pump (SAP) therapy with predictive low glucose suspend (PLGS) feature in improving glucose control. Aim of our study was to evaluate the effect on metabolic control and glucose variability of the switch from SAP therapy with PLGS to a HCL system in type 1 diabetic individuals. Forty adults with type 1 diabetes, who had been using SAP therapy with PLGS feature (Minimed 640G; Medtronic, Northridge, CA) for at least 12 months were evaluated in a 6-month case-control observational retrospective study. Twenty subjects who consecutively switched from Minimed 640G to a HCL system (Minimed 670G; Medtronic) (670G group) were compared with a control group consisting of 20 subjects who continued with the MiniMed 640G pump (640G group) matched for age, gender, and HbA1c. At the end of the study there was a significant reduction in average HbA1c levels (-4.9 ± 6.4 mmol/mol [-0.4% ± 0.6%], P < 0.01), sensor glucose concentrations (-15.4 ± 17.7 mg/dL, P < 0.005), coefficient of variation of sensor glucose concentrations (-3.8% ± 3.6%, P < 0.01), percentage time spent in both hyperglycemic range 181-250 mg/dL (-5.1% ± 4.5%, P < 0.05), and >250 mg/dL (-6.1% ± 6.9%, P < 0.05) in the 670G group, whereas they remained unchanged in the 640G group. Percentage of time spent in euglycemic range significantly increased (11.6% ± 8.3%, P < 0.005) only in the 670G group. There was no change in time spent in hypoglycemic range in both groups. In adults with type 1 diabetes, switching from a 640G to a 670G system significantly improved glucose control and reduced glucose variability, thus reaching in most cases the recommended targets for time spent in euglycemic and hyperglycemic ranges without increasing the risk of hypoglycemia.

Published
2020

10. Continuous subcutaneous insulin infusion reduces maternal and neonatal risk in pregnant women with type 1 diabetes: An observational cohort study of 122 pregnancies

Author

Dodesini, A, Cavalli, G, Ciriello, E, Lepore, G, Corsi, A, Scaranna, C, Bellante, R, Albizzi, M, Galliani, S, Mangili, G, Trevisan, R, Dodesini A. R., Cavalli G., Ciriello E., Lepore G., Corsi A., Scaranna C., Bellante R., Albizzi M., Galliani S., Mangili G., Trevisan R., Dodesini, A, Cavalli, G, Ciriello, E, Lepore, G, Corsi, A, Scaranna, C, Bellante, R, Albizzi, M, Galliani, S, Mangili, G, Trevisan, R, Dodesini A. R., Cavalli G., Ciriello E., Lepore G., Corsi A., Scaranna C., Bellante R., Albizzi M., Galliani S., Mangili G., and Trevisan R.

Published
2020

11. Sitagliptin treatment at the time of hospitalization was associated with reduced mortality in patients with type 2 diabetes and covid-19: A multicenter case-control retrospective observational study

Author

Solerte, S, D'Addio, F, Trevisan, R, Lovati, E, Rossi, A, Pastore, I, Acqua, M, Ippolito, E, Scaranna, C, Bellante, R, Galliani, S, Dodesini, A, Lepore, G, Geni, F, Fiorina, R, Catena, E, Corsico, A, Colombo, R, Mirani, M, Riva De, C, Oleandri, S, Abdi, R, Bonventre, J, Rusconi, S, Folli, F, Sabatino, A, Zuccotti, G, Galli, M, Fiorina, P, Solerte S. B., D'Addio F., Trevisan R., Lovati E., Rossi A., Pastore I., Acqua M. D., Ippolito E., Scaranna C., Bellante R., Galliani S., Dodesini A. R., Lepore G., Geni F., Fiorina R. M., Catena E., Corsico A., Colombo R., Mirani M., Riva De C., Oleandri S. E., Abdi R., Bonventre J. V., Rusconi S., Folli F., Sabatino A. D., Zuccotti G., Galli M., Fiorina P., Solerte, S, D'Addio, F, Trevisan, R, Lovati, E, Rossi, A, Pastore, I, Acqua, M, Ippolito, E, Scaranna, C, Bellante, R, Galliani, S, Dodesini, A, Lepore, G, Geni, F, Fiorina, R, Catena, E, Corsico, A, Colombo, R, Mirani, M, Riva De, C, Oleandri, S, Abdi, R, Bonventre, J, Rusconi, S, Folli, F, Sabatino, A, Zuccotti, G, Galli, M, Fiorina, P, Solerte S. B., D'Addio F., Trevisan R., Lovati E., Rossi A., Pastore I., Acqua M. D., Ippolito E., Scaranna C., Bellante R., Galliani S., Dodesini A. R., Lepore G., Geni F., Fiorina R. M., Catena E., Corsico A., Colombo R., Mirani M., Riva De C., Oleandri S. E., Abdi R., Bonventre J. V., Rusconi S., Folli F., Sabatino A. D., Zuccotti G., Galli M., and Fiorina P.

Abstract

OBJECTIVE Poor outcomes have been reported in patients with type 2 diabetes and coronavirus disease 2019 (COVID-19); thus, it is mandatory to explore novel therapeutic approaches for this population. RESEARCH DESIGN AND METHODS In a multicenter, case-control, retrospective, observational study, sitagliptin, an oral and highly selective dipeptidyl peptidase 4 inhibitor, was added to standard of care (e.g., insulin administration) at the time of hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19. Every center also recruited at a 1:1 ratio untreated control subjects matched for age and sex. All patients had pneumonia and exhibited oxygen saturation <95% when breathing ambient air or when receiving oxygen support. The primary end points were discharge from the hospital/death and improvement of clinical outcomes, defined as an increase in at least two points on a seven-category modified ordinal scale. Data were collected retrospectively from patients receiving sitagliptin from 1 March through 30 April 2020. RESULTS Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted in Northern Italy hospitals included in this study, 169 were on sitagliptin, while 169 were on standard of care. Treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs. 37% of deceased patients; hazard ratio 0.44 [95% CI 0.29–0.66]; P = 0.0001), with an improvement in clinical outcomes (60% vs. 38% of improved patients; P = 0.0001) and with a greater number of hospital discharges (120 vs. 89 of discharged patients; P = 0.0008) compared with patients receiving standard of care, respectively. CONCLUSIONS In this multicenter, case-control, retrospective, observational study of patients with type 2 diabetes admitted to the hospital for COVID-19, sitagliptin treatment at the time of hospitalization was associated with reduced mortality and improved clinical outcomes as compared with standard-of-care treatme

Published
2020

12. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., Marigliano M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., and Marigliano M.

Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and [removed]18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

13. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., Capuano G., Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., and Capuano G.

Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes.

Published
2018

14. ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide

Author

Bossi, A. C., De Mori, V., Scaranna, C., Veronesi, G., Lepore, G., Barbara, A., Rosalia, B., Antonio, B., Denise, B., Silvia, B., Sergio, C., Milena, C., Stefano, E., Ivano, F., Margherita, G., Giosue, G., Elisabetta, L., Pietro, L., Elena, M. M., Giuseppina, M., Giancarla, M., Emanuela, O., Eva, P., Fabrizio, Q., Giorgio, R., Joselita, R., Cecilia, S. S., Luca, Z., Pietro, B. D., Mario, B., Silvia, C., Annalisa, C., Francesco, D. A., Viviana, M., Enzo, M. L., Cristina, M., Micol, P., Antonio, P., Donata, R., Giovanni, R., and Emanuela, Z.

Subjects
medicine.medical_specialty, Waist, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, Body weight, Dulaglutide, Glycemic control, Real-life study, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Glycemic, Original Research, business.industry, medicine.disease, chemistry, Observational study, Glycated hemoglobin, business, medicine.drug
Abstract

Introduction Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-primary outcomes) for up to 24 months in the real-life setting in consecutive outpatients with type 2 diabetes (T2D) who initiated dulaglutide. Co-secondary outcomes were durability of treatment effects on both glycated hemoglobin (HbA1c) and body weight. Methods Overall, 1584 subjects (696 women, 888 men) with T2D (mean age [± standard deviation] 61.7 ± 10.2 years; mean T2D duration 9.9 ± 6.9 years) were treated with dulaglutide (0.75 or 1.5 mg once weekly) between April 2016 and December 2019. Results A total of 1130 patients completed 12 months of follow-up, while 170 patients interrupted treatment before the 12-month endpoint. At 12 months, average HbA1c and average fasting plasma glucose (FPG) were significantly lower compared to baseline levels (− 10 mmol/mol and − 24.9 mg/dL, respectively), as were body weight (− 3.4 kg) and waist circumference (− 3.3 cm) values (all p

Published
2020

15. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., Agrusta M., Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., and Agrusta M.

Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 p

Published
2017

17. Sex differences in food choices, adherence to dietary recommendations and plasma lipid profile in type 2 diabetes

Author

Vitale, M., Masulli, M., Cocozza, S., Anichini, R., Babini, A., Boemi, M., Bonora, E., Buzzetti, R., Carpinteri, R., Caselli, C., Ceccarelli, E., Cignarelli, M., Citro, G., Clemente, G., Consoli A, C., De Gregorio, A., Di Bartolo, P., Di Cianni, G., Fontana, L., Garofolo, M., Giorda, C., Giordano, C., Grioni, S., Iovine, C., Longhitano, S., Mancastroppa, G., Mazzucchelli, C., Montani, V., Mori, M., Perriello, G., Rinaldi, M., Ruffo, M., Salvi, L., Sartore, G., Scaranna, C., Tonutti, L., Zamboni, C., Zogheri, A., Krogh, V., Cappellini, F., Signorini, S., Riccardi, G., Vaccaro, O., IT Study Group, T., Vitale M1, Masulli M, Cocozza S, Anichini R, Babini AC, Boemi M, Bonora E, Buzzetti R, Carpinteri R, Caselli C, Ceccarelli E, Cignarelli M, Citro G, Clemente G, Consoli A, Corsi L, De Gregorio A, Di Bartolo P, Di Cianni G, Fontana L, Garofolo M, Giorda CB, Giordano C, Grioni S, Iovine C, Longhitano S, Mancastroppa G, Mazzucchelli C, Montani V, Mori M, Perriello G, Rinaldi ME, Ruffo MC, Salvi L, Sartore G, Scaranna C, Tonutti L, Zamboni C, Zogheri A, Krogh V, Cappellini F, Signorini S, Riccardi G, Vaccaro O, and TOSCA.IT Study Group.

Subjects
tosca,Diabetes,Dietary habits,Nutritional recommendations,Sex differences,Men,Women,Cardiovascular risk factors
Abstract

Background and aims Diabetic women have a more adverse plasma lipid profile than men. Sex differences in dietary habits may play a role, but are little investigated. The study evaluates the quality of diet, adherence to the nutritional recommendations of the Diabetes and Nutrition Study Group and their relation with plasma lipid in men and women with diabetes. Methods and results We studied 2573 people, aged 50–75, enrolled in the TOSCA.IT study (clinicaltrials.gov; NCT00700856). Plasma lipids were measured centrally. Diet was assessed with a semi-quantitative food frequency questionnaire. Women had a more adverse plasma lipid profile than men. Women consumed significantly more legumes, vegetables, fruits, eggs, milk, vegetable oils, and added sugar, whereas men consumed more starchy foods, soft drinks and alcoholic beverages. This stands for a higher proportion (%) of energy intake from saturated fat and added sugar (12.0 ± 2.4 vs 11.5 ± 2.5 and 3.4 ± 3.2 vs 2.3 ± 3.2, P < 0.04), and a higher intake of fiber (11.2 ± 2.8 vs 10.4 ± 2.6 g/1000 Kcal/day) in women. Adherence to the recommendations for saturated fat and fiber consumption was associated with significantly lower LDL-cholesterol regardless of sex. Adherence to the recommendations for added sugars was associated with significantly lower triglycerides and higher HDL-cholesterol in men and women. Conclusions Men and women with diabetes show significant differences in adherence to nutritional recommendations, but sex differences in plasma lipid profile are unlikely to be explained by nutritional factors. Adherence to the nutritional recommendations is associated with a better plasma lipid profile regardless of sex, thus reinforcing the importance of substituting saturated for unsaturated fat sources, increasing fiber and reducing added sugar intake.

Published
2016

19. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Lepore, Giuseppe, primary, Bonfanti, Riccardo, additional, Bozzetto, Lutgarda, additional, Di Blasi, Vincenzo, additional, Girelli, Angela, additional, Grassi, Giorgio, additional, Iafusco, Dario, additional, Laviola, Luigi, additional, Rabbone, Ivana, additional, Schiaffini, Riccardo, additional, Bruttomesso, Daniela, additional, Mammì, F., additional, Bruzzese, M., additional, Schettino, M., additional, Nuzzo, M.G., additional, Di Blasi, V., additional, Fresa, R., additional, Lambiase, C., additional, Iafusco, D., additional, Zanfardino, A., additional, Confetto, S., additional, Bozzetto, L., additional, Annuzzi, G., additional, Alderisio, A., additional, Riccardi, G., additional, Gentile, S., additional, Marino, G., additional, Guarino, G., additional, Zucchini, S., additional, Maltoni, G., additional, Suprani, T., additional, Graziani, V., additional, Nizzoli, M., additional, Acquati, S., additional, Cavani, R., additional, Romano, S., additional, Michelini, M., additional, Manicardi, E., additional, Bonadonna, R., additional, Dei Cas, A., additional, Dall'aglio, E., additional, Papi, M., additional, Riboni, S., additional, Manicardi, V., additional, Pugni, V., additional, Lasagni, A., additional, Street, M.E., additional, Pagliani, U., additional, Rossi, C., additional, Assaloni, R., additional, Brunato, B., additional, Tortul, C., additional, Zanette, G., additional, Li Volsi, P., additional, Zanatta, M., additional, Tonutti, L., additional, Agus, S., additional, Pellegrini, M.A., additional, Ceccano, P., additional, Pozzilli, G., additional, Anguissola, Beretta, additional, Buzzetti, R., additional, Moretti C, C., additional, Leto, G., additional, Pozzilli, P., additional, Manfrini, S., additional, Maurizi, A.R., additional, Leotta, S., additional, Altomare, M., additional, Abbruzzese, S., additional, Carletti, S., additional, Suraci, C., additional, Filetti, S., additional, Manca Bitti, M.L., additional, Arcano, S., additional, Cavallo, M.G., additional, De Bernardinis, M., additional, Pitocco, D., additional, Caputo, S., additional, Rizzi, A., additional, Manto, A., additional, Schiaffini, R., additional, Cappa, M., additional, Benevento, D., additional, Frontoni, S., additional, Malandrucco, I., additional, Morano, S., additional, Filardi, T., additional, Lauro, D., additional, Marini, M.A., additional, Castaldo, E., additional, Sabato, D., additional, Tuccinardi, F., additional, Forte, E., additional, Viterbori, P., additional, Arnaldi, C., additional, Minuto, N., additional, d'Annunzio, G., additional, Corsi, A., additional, Rota, R., additional, Scaranna, C., additional, Trevisan, R., additional, Valentini, U., additional, Girelli, A., additional, Bonfadini, S., additional, Zarra, E., additional, Plebani, A., additional, Prandi, E., additional, Felappi, B., additional, Rocca, A., additional, Meneghini, E., additional, Galli, P., additional, Ruggeri, P., additional, Carrai, E., additional, Fugazza, L., additional, Baggi, V., additional, Conti, D., additional, Bosi, E., additional, Laurenzi, A., additional, Caretto, A., additional, Molinari, C., additional, Orsi, E., additional, Grancini, V., additional, Resi, V., additional, Bonfanti, R., additional, Favalli, V., additional, Bonura, C., additional, Rigamonti, A., additional, Bonomo, M., additional, Bertuzzi, F., additional, Pintaudi, B., additional, Disoteo, O., additional, Perseghin, G., additional, Perra, S., additional, Chiovato, L., additional, De Cata, P., additional, Zerbini, F., additional, Lovati, E., additional, Laneri, M., additional, Guerraggio, L., additional, Bossi, A.C., additional, De Mori, V., additional, Galetta, M., additional, Meloncelli, I., additional, Aiello A, A., additional, Di Vincenzo, S., additional, Nuzzi, A., additional, Fraticelli, E., additional, Ansaldi, E., additional, Battezzati, M., additional, Lombardi, M., additional, Balbo, M., additional, Lera, R., additional, Secco, A., additional, De Donno, V., additional, Cadario, F., additional, Savastio, S., additional, Ponzani, C., additional, Aimaretti, G., additional, Rabbone, I., additional, Ignaccolo, G., additional, Tinti, D., additional, Cerutti, F., additional, Bari, F., additional, Giorgino, F., additional, Piccinno, E., additional, Zecchino, O., additional, Cignarelli, M., additional, Lamacchia, O., additional, Picca, G., additional, De Cosmo, S., additional, Rauseo, A., additional, Tomaselli, L., additional, Tumminia, A., additional, Egiziano, C., additional, Scarpitta, A.M., additional, Maggio, F., additional, Cardella, F., additional, Roppolo, R., additional, Provenzano, V., additional, Fleres, M., additional, Scorsone, A., additional, Scatena, A., additional, Gregori, G., additional, Lucchesi, S., additional, Gadducci, F., additional, Di Cianni, S., additional, Pancani, S., additional, Del Prato, S., additional, Aragona, M., additional, Crisci, I., additional, Calianno, A., additional, Fattor, B., additional, Crazzolara, D., additional, Reinstadler, P., additional, Longhi, S., additional, Incelli, G., additional, Rauch, S., additional, Romanelli, T., additional, Orrasch, M., additional, Cauvin, V., additional, Franceschi, R., additional, Lalli, C., additional, Pianta, A., additional, Marangoni, A., additional, Aricò, C.N., additional, Marin, N., additional, Nogara, N., additional, Simioni, N., additional, Filippi, A., additional, Gidoni Guarneri, G.L., additional, Contin M.L, M.L., additional, Decata, A.P., additional, Bondesan, L., additional, Confortin, L., additional, Coracina, A., additional, Lombardi, S., additional, Costa Padova, S., additional, Cipponeri, E., additional, Scotton, R., additional, Galasso, S., additional, Boscari, F., additional, Zanon, M.S., additional, Vinci, C., additional, Lisato, G., additional, Gottardo, L., additional, Bonora, E., additional, Trombetta, M., additional, Negri, C., additional, Brangani, C., additional, Maffeis, C., additional, Sabbion, A., additional, and Marigliano, M., additional

Published
2018
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21. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

22. Studio della correlazione tra uricemia e variabili metaboliche nella popolazione generale. Dati dello studio Pamela

Author

BOMBELLI, MICHELE, Scaranna, C, GRASSI, GUIDO, SCARANNA, CRISTIANA, BOMBELLI, MICHELE, Scaranna, C, GRASSI, GUIDO, and SCARANNA, CRISTIANA

Abstract

SCOPI: Lo scopo del nostro studio è valutare la rilevanza clinica del dosaggio dell'uricemia in soggetti in sovrappeso appartenenti ad una popolazione generale urbana del Nord Italia. Tale scopo è stato perseguito mediante l'analisi dei seguenti due aspetti: studio della correlazione tra i livelli di acido urico e i parametri metabolici; valore predittivo dell’uricemia nei confronti della mortalità totale e cardiovascolare in soggetti in sovrappeso o caratterizzati da incremento del girovita. MATERIALI E METODI: per il nostro studio abbiamo analizzato i dati ricavati dagli accertamenti eseguiti su 2045 soggetti che hanno preso parte allo studio Pamela. Uno studio condotto nell’area della città di Monza tra il 1990 e il 1993 fino al 2009 per un follow up complessivo di 17 anni. Ad ogni soggetto è stato prelevato un campione di sangue per l’analisi della glicemia, colesterolemia totale e frazionata, trigliceridemia, dell’emoglobina glicosilata e dell’acido urico sierico. E' stata effettuata la misurazione dell'indice di massa corporea (BMI) mediante formula k/m2. L'adiposità addominale è stata misurata attraverso la circonferenza vita (CV). RISULTATI: 1033 soggetti (51.7%) con BMI ≥ 25 k/m2 e 840 soggetti (43.3%) con circonferenza vita ≥ 80 cm (F) - 94 cm (M) sono stati selezionati per la nostra analisi finale. Ulteriori analisi sono state effettuate in due sottopopolazioni costituite da 271 soggetti obesi (BMI ≥ 30 K/m2) e 383 soggetti con girovita francamente aumentato (CV ≥ 88 (F) cm / 102 (M) cm). I soggetti obesi (BMI ≥ 30 k/m2) ed in sovrappeso (BMI ≥ 25 k/m2) presentavano livelli medi di acido urico significativamente più elevati rispetto al resto della popolazione. Allo stesso modo i soggetti con girovita aumentato (CV ≥ 80 cm (F) - 94 cm (M) e francamente elevato (CV ≥ 88 (F) / 102 (M) cm) avevano livelli medi di acido urico significativamente più elevati rispetto al resto della popolazione. I dati conservavano la loro significatività statistica anc

Published
2013

24. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Giuseppe Lepore, Riccardo Bonfanti, Lutgarda Bozzetto, Vincenzo Di Blasi, Angela Girelli, Giorgio Grassi, Dario Iafusco, Luigi Laviola, Ivana Rabbone, Riccardo Schiaffini, Daniela Bruttomesso, F. Mammì, M. Bruzzese, M. Schettino, M.G. Nuzzo, V. Di Blasi, R. Fresa, C. Lambiase, D. Iafusco, A. Zanfardino, S. Confetto, L. Bozzetto, G. Annuzzi, A. Alderisio, G. Riccardi, S. Gentile, G. Marino, G. Guarino, S. Zucchini, G. Maltoni, T. Suprani, V. Graziani, M. Nizzoli, S. Acquati, R. Cavani, S. Romano, M. Michelini, E. Manicardi, R. Bonadonna, A. Dei Cas, E. Dall'aglio, M. Papi, S. Riboni, V. Manicardi, V. Pugni, A. Lasagni, M.E. Street, U. Pagliani, C. Rossi, R. Assaloni, B. Brunato, C. Tortul, G. Zanette, P. Li Volsi, M. Zanatta, L. Tonutti, S. Agus, M.A. Pellegrini, P. Ceccano, G. Pozzilli, Beretta Anguissola, R. Buzzetti, C. Moretti C, G. Leto, P. Pozzilli, S. Manfrini, A.R. Maurizi, S. Leotta, M. Altomare, S. Abbruzzese, S. Carletti, C. Suraci, S. Filetti, M.L. Manca Bitti, S. Arcano, M.G. Cavallo, M. De Bernardinis, D. Pitocco, S. Caputo, A. Rizzi, A. Manto, R. Schiaffini, M. Cappa, D. Benevento, S. Frontoni, I. Malandrucco, S. Morano, T. Filardi, D. Lauro, M.A. Marini, E. Castaldo, D. Sabato, F. Tuccinardi, E. Forte, P. Viterbori, C. Arnaldi, N. Minuto, G. d'Annunzio, A. Corsi, R. Rota, C. Scaranna, R. Trevisan, U. Valentini, A. Girelli, S. Bonfadini, E. Zarra, A. Plebani, E. Prandi, B. Felappi, A. Rocca, E. Meneghini, P. Galli, P. Ruggeri, E. Carrai, L. Fugazza, V. Baggi, D. Conti, E. Bosi, A. Laurenzi, A. Caretto, C. Molinari, E. Orsi, V. Grancini, V. Resi, R. Bonfanti, V. Favalli, C. Bonura, A. Rigamonti, M. Bonomo, F. Bertuzzi, B. Pintaudi, O. Disoteo, G. Perseghin, S. Perra, L. Chiovato, P. De Cata, F. Zerbini, E. Lovati, M. Laneri, L. Guerraggio, A.C. Bossi, V. De Mori, M. Galetta, I. Meloncelli, A. Aiello A, S. Di Vincenzo, A. Nuzzi, E. Fraticelli, E. Ansaldi, M. Battezzati, M. Lombardi, M. Balbo, R. Lera, A. Secco, V. De Donno, F. Cadario, S. Savastio, C. Ponzani, G. Aimaretti, I. Rabbone, G. Ignaccolo, D. Tinti, F. Cerutti, F. Bari, F. Giorgino, E. Piccinno, O. Zecchino, M. Cignarelli, O. Lamacchia, G. Picca, S. De Cosmo, A. Rauseo, L. Tomaselli, A. Tumminia, C. Egiziano, A.M. Scarpitta, F. Maggio, F. Cardella, R. Roppolo, V. Provenzano, M. Fleres, A. Scorsone, A. Scatena, G. Gregori, S. Lucchesi, F. Gadducci, S. Di Cianni, S. Pancani, S. Del Prato, M. Aragona, I. Crisci, A. Calianno, B. Fattor, D. Crazzolara, P. Reinstadler, S. Longhi, G. Incelli, S. Rauch, T. Romanelli, M. Orrasch, V. Cauvin, R. Franceschi, C. Lalli, A. Pianta, A. Marangoni, C.N. Aricò, N. Marin, N. Nogara, N. Simioni, A. Filippi, G.L. Gidoni Guarneri, M.L. Contin M.L, A.P. Decata, L. Bondesan, L. Confortin, A. Coracina, S. Lombardi, S. Costa Padova, E. Cipponeri, R. Scotton, S. Galasso, F. Boscari, M.S. Zanon, C. Vinci, G. Lisato, L. Gottardo, E. Bonora, M. Trombetta, C. Negri, C. Brangani, C. Maffeis, A. Sabbion, M. Marigliano, Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Laviola, Luigi, Rabbone, Ivana, Schiaffini, Riccardo, Bruttomesso, Daniela, Lepore, G., Bonfanti, R., Bozzetto, L., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Laviola, L., Rabbone, I., Schiaffini, R., Bruttomesso, D., Mammi, F., Bruzzese, M., Schettino, M., Nuzzo, M. G., Fresa, R., Lambiase, C., Zanfardino, A., Confetto, S., Annuzzi, G., Alderisio, A., Riccardi, G., Gentile, S., Marino, G., Guarino, G., Zucchini, S., Maltoni, G., Suprani, T., Graziani, V., Nizzoli, M., Acquati, S., Cavani, R., Romano, S., Michelini, M., Manicardi, E., Bonadonna, R., Dei Cas, A., Dall'Aglio, E., Papi, M., Riboni, S., Manicardi, V., Pugni, V., Lasagni, A., Street, M. E., Pagliani, U., Rossi, C., Assaloni, R., Brunato, B., Tortul, C., Zanette, G., Li Volsi, P., Zanatta, M., Tonutti, L., Agus, S., Pellegrini, M. A., Ceccano, P., Pozzilli, G., Anguissola, B., Buzzetti, R., Moretti C, C., Leto, G., Pozzilli, P., Manfrini, S., Maurizi, A. R., Leotta, S., Altomare, M., Abbruzzese, S., Carletti, S., Suraci, C., Filetti, S., Manca Bitti, M. L., Arcano, S., Cavallo, M. G., De Bernardinis, M., Pitocco, D., Caputo, S., Rizzi, A., Manto, A., Cappa, M., Benevento, D., Frontoni, S., Malandrucco, I., Morano, S., Filardi, T., Lauro, D., Marini, M. A., Castaldo, E., Sabato, D., Tuccinardi, F., Forte, E., Viterbori, P., Arnaldi, C., Minuto, N., D'Annunzio, G., Corsi, A., Rota, R., Scaranna, C., Trevisan, R., Valentini, U., Bonfadini, S., Zarra, E., Plebani, A., Prandi, E., Felappi, B., Rocca, A., Meneghini, E., Galli, P., Ruggeri, P., Carrai, E., Fugazza, L., Baggi, V., Conti, D., Bosi, E., Laurenzi, A., Caretto, A., Molinari, C., Orsi, E., Grancini, V., Resi, V., Favalli, V., Bonura, C., Rigamonti, A., Bonomo, M., Bertuzzi, F., Pintaudi, B., Disoteo, O., Perseghin, G., Perra, S., Chiovato, L., De Cata, P., Zerbini, F., Lovati, E., Laneri, M., Guerraggio, L., Bossi, A. C., De Mori, V., Galetta, M., Meloncelli, I., Aiello A, A., Di Vincenzo, S., Nuzzi, A., Fraticelli, E., Ansaldi, E., Battezzati, M., Lombardi, M., Balbo, M., Lera, R., Secco, A., De Donno, V., Cadario, F., Savastio, S., Ponzani, C., Aimaretti, G., Ignaccolo, G., Tinti, D., Cerutti, F., Bari, F., Giorgino, F., Piccinno, E., Zecchino, O., Cignarelli, M., Lamacchia, O., Picca, G., De Cosmo, S., Rauseo, A., Tomaselli, L., Tumminia, A., Egiziano, C., Scarpitta, A. M., Maggio, F., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Scorsone, A., Scatena, A., Gregori, G., Lucchesi, S., Gadducci, F., Di Cianni, S., Pancani, S., Del Prato, S., Aragona, M., Crisci, I., Calianno, A., Fattor, B., Crazzolara, D., Reinstadler, P., Longhi, S., Incelli, G., Rauch, S., Romanelli, T., Orrasch, M., Cauvin, V., Franceschi, R., Lalli, C., Pianta, A., Marangoni, A., Arico, C. N., Marin, N., Nogara, N., Simioni, N., Filippi, A., Gidoni Guarneri, G. L., Contin, M. L M. L., Decata, A. P., Bondesan, L., Confortin, L., Coracina, A., Lombardi, S., Costa Padova, S., Cipponeri, E., Scotton, R., Galasso, S., Boscari, F., Zanon, M. S., Vinci, C., Lisato, G., Gottardo, L., Bonora, E., Trombetta, M., Negri, C., Brangani, C., Maffeis, C., Sabbion, A., Marigliano, M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, and Marigliano, M

Subjects
Blood Glucose, Male, Pediatrics, Acute and chronic complication, Glycated Hemoglobin A, Time Factors, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Medicine (miscellaneous), Ketosi, Infusions, Subcutaneous, Settore MED/13 - Endocrinologia, Acute and chronic complications, Continuous subcutaneous insulin infusion (CSII), Diabetes mellitus, Metabolic control, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, 0302 clinical medicine, Endocrinology, Adolescent, Adult, Albuminuria, Biomarkers, Child, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy, Female, Health Care Surveys, Humans, Hypertension, Hypoglycemia, Hypoglycemic Agents, Insulin, Italy, Ketosis, Middle Aged, Risk Factors, Treatment Outcome, Young Adult, Insulin Infusion Systems, 030212 general & internal medicine, Subcutaneous, Diabetic retinopathy, Diabetes and Metabolism, medicine.symptom, Type 2, Human, Type 1, Insulin pump, Infusions, medicine.medical_specialty, Diabetes mellitu, Time Factor, 030209 endocrinology & metabolism, 03 medical and health sciences, medicine, Cross-Sectional Studie, Glycated Hemoglobin, Type 1 diabetes, Hypoglycemic Agent, business.industry, Risk Factor, Biomarker, medicine.disease, Ketoacidosis, Infusions, Subcutaneou, Health Care Survey, Diabetic Nephropathie, business
Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. 18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

25. Switching to the Minimed™ 780G system achieves clinical targets for CGM in adults with type 1 diabetes regardless of previous insulin strategy and baseline glucose control

Author

Giuseppe Lepore, Alessandro Rossini, Rosalia Bellante, Anna Corsi, Cristiana Scaranna, Alessandro Roberto Dodesini, Roberto Trevisan, Lepore, G, Rossini, A, Bellante, R, Corsi, A, Scaranna, C, Dodesini, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, Advanced hybrid closed-loop system, Glucose sensor, Continuous subcutaneous insulin infusion, Blood Glucose Self-Monitoring, Endocrinology, Diabetes and Metabolism, General Medicine, Middle Aged, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Endocrinology, Internal Medicine, Insulin therapy, Humans, Hypoglycemic Agents, Insulin, Female, Insulin pump, Type 1 diabetes mellitu, Retrospective Studies
Abstract

Aims: Advanced hybrid closed-loop (AHCL) systems represent the latest introduction in the treatment of type 1 diabetes (T1DM). Randomized controlled trials and real-world evidence studies showed that AHCL systems are a safe and effective insulin management strategy. Aim of this retrospective, single-center, real-life study was to evaluate the effect on metabolic control, evaluated by continuous glucose monitoring (CGM) metrics, of the switch from four available insulin strategies to an AHCL system in adult patients with type 1 diabetes. Methods: A total of 102 patients with T1DM (mean age 42.1 ± 16.3 years, males/females 47/55, duration of diabetes 21.4 ± 13.3 years, BMI 24.4 ± 4.5 kg/m2, HbA1c 59.9 ± 9.6 mmol/mol or 7.6 ± 0.9%), treated with four different insulin therapies [multiple daily insulin (MDI) therapy, continuous subcutaneous insulin infusion (CSII), sensor-augmented pump (SAP) with predictive low-glucose suspend (PLGS), and hybrid closed loop (HCL) system] were evaluated before hand, two months and six months after switching to an AHCL (Minimed™ 780G system, Medtronic, Northridge, CA) system. Results: Two months after the switch, mean GCM metrics improved in all four treatment groups. Six months after the switch, the participants of all four groups achieved a mean GMI < 53 mmol/mol, TIR > 70%, TBR < 4%, and CV < 36%, which is recommended by the ADA Standard of Medical Care in Diabetes 2022, including the MDI group with worse baseline glycemic control. Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to six months independently of previous insulin treatment and baseline conditions.

Published
2022
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26. Real-World Insulin Treatment in Pregnant Women with Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System

Author

Alessandro Roberto Dodesini, Nicolò Diego Borella, Giuseppe Lepore, Silvia Bonfadini, Anna Corsi, Cristiana Scaranna, Rosalia Bellante, Roberto Trevisan, Dodesini, A, Borella, N, Lepore, G, Corsi, A, Bonfadini, S, Bellante, R, Scaranna, C, and Trevisan, R

Subjects
Medical Laboratory Technology, Endocrinology, Endocrinology, Diabetes and Metabolism, Type 1 diabetes, Pregnancy, aHCL, CGM metrics
Published
2023
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27. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study

Author

Marco Mirani, Riccardo Colombo, Ida Pastore, Rosalia Bellante, Francesca D'Addio, Angelo Corsico, Alessandro Roberto Dodesini, Cristiana Scaranna, Silvia Galliani, Sebastiano Bruno Solerte, Roberto Trevisan, Elisabetta Lovati, Giuseppe Lepore, Franco Folli, Emanuele Catena, Salvatore Endrio Oleandri, Marco Dell’Acqua, Antonio Rossi, Elio Ippolito, Francesca Geni, Antonio Di Sabatino, Carlo De Riva, Gian Vincenzo Zuccotti, Paolo Fiorina, Roberta Maria Fiorina, Reza Abdi, Massimo Galli, Joseph V. Bonventre, Stefano Rusconi, Solerte, S, D'Addio, F, Trevisan, R, Lovati, E, Rossi, A, Pastore, I, Acqua, M, Ippolito, E, Scaranna, C, Bellante, R, Galliani, S, Dodesini, A, Lepore, G, Geni, F, Fiorina, R, Catena, E, Corsico, A, Colombo, R, Mirani, M, Riva De, C, Oleandri, S, Abdi, R, Bonventre, J, Rusconi, S, Folli, F, Sabatino, A, Zuccotti, G, Galli, M, and Fiorina, P

Subjects
medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Coronaviru, Pneumonia, Viral, Population, 030209 endocrinology & metabolism, Type 2 diabetes, Dipeptidyl peptidase-4 inhibitor, Sitagliptin Phosphate, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, 030212 general & internal medicine, education, Advanced and Specialized Nursing, education.field_of_study, Betacoronaviru, Pandemic, Emerging Therapies: Drugs and Regimens, SARS-CoV-2, Coronavirus Infection, business.industry, Hazard ratio, COVID-19, Retrospective cohort study, medicine.disease, Hospitalization, Italy, Diabetes Mellitus, Type 2, Sitagliptin, business, Human, medicine.drug
Abstract

OBJECTIVE Poor outcomes have been reported in patients with type 2 diabetes and coronavirus disease 2019 (COVID-19); thus, it is mandatory to explore novel therapeutic approaches for this population. RESEARCH DESIGN AND METHODS In a multicenter, case-control, retrospective, observational study, sitagliptin, an oral and highly selective dipeptidyl peptidase 4 inhibitor, was added to standard of care (e.g., insulin administration) at the time of hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19. Every center also recruited at a 1:1 ratio untreated control subjects matched for age and sex. All patients had pneumonia and exhibited oxygen saturation RESULTS Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted in Northern Italy hospitals included in this study, 169 were on sitagliptin, while 169 were on standard of care. Treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs. 37% of deceased patients; hazard ratio 0.44 [95% CI 0.29–0.66]; P = 0.0001), with an improvement in clinical outcomes (60% vs. 38% of improved patients; P = 0.0001) and with a greater number of hospital discharges (120 vs. 89 of discharged patients; P = 0.0008) compared with patients receiving standard of care, respectively. CONCLUSIONS In this multicenter, case-control, retrospective, observational study of patients with type 2 diabetes admitted to the hospital for COVID-19, sitagliptin treatment at the time of hospitalization was associated with reduced mortality and improved clinical outcomes as compared with standard-of-care treatment. The effects of sitagliptin in patients with type 2 diabetes and COVID-19 should be confirmed in an ongoing randomized, placebo-controlled trial.

Published
2020

28. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case–Control Study

Author

Giuseppe Lepore, Anna Maria Corsi, Alessandro Roberto Dodesini, Roberto Trevisan, Cristiana Scaranna, Lepore, G, Scaranna, C, Corsi, A, Dodesini, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Glucose control, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Glycemic Control, Low insulin, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, Hybrid closed-loop system, Predictive low glucose suspend, Sensor-augmented pump, Type 1 diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Low glucose suspend, Retrospective Studies, business.industry, Blood Glucose Self-Monitoring, Case-control study, Middle Aged, medicine.disease, Hypoglycemia, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Treatment Outcome, Feature (computer vision), Case-Control Studies, Cardiology, Female, Observational study, business, Closed loop
Abstract

There are no data whether hybrid closed-loop (HCL) systems are superior to sensor-augmented pump (SAP) therapy with predictive low glucose suspend (PLGS) feature in improving glucose control. Aim of our study was to evaluate the effect on metabolic control and glucose variability of the switch from SAP therapy with PLGS to a HCL system in type 1 diabetic individuals. Forty adults with type 1 diabetes, who had been using SAP therapy with PLGS feature (Minimed 640G; Medtronic, Northridge, CA) for at least 12 months were evaluated in a 6-month case-control observational retrospective study. Twenty subjects who consecutively switched from Minimed 640G to a HCL system (Minimed 670G; Medtronic) (670G group) were compared with a control group consisting of 20 subjects who continued with the MiniMed 640G pump (640G group) matched for age, gender, and HbA1c. At the end of the study there was a significant reduction in average HbA1c levels (-4.9 ± 6.4 mmol/mol [-0.4% ± 0.6%], P < 0.01), sensor glucose concentrations (-15.4 ± 17.7 mg/dL, P < 0.005), coefficient of variation of sensor glucose concentrations (-3.8% ± 3.6%, P < 0.01), percentage time spent in both hyperglycemic range 181-250 mg/dL (-5.1% ± 4.5%, P < 0.05), and >250 mg/dL (-6.1% ± 6.9%, P < 0.05) in the 670G group, whereas they remained unchanged in the 640G group. Percentage of time spent in euglycemic range significantly increased (11.6% ± 8.3%, P < 0.005) only in the 670G group. There was no change in time spent in hypoglycemic range in both groups. In adults with type 1 diabetes, switching from a 640G to a 670G system significantly improved glucose control and reduced glucose variability, thus reaching in most cases the recommended targets for time spent in euglycemic and hyperglycemic ranges without increasing the risk of hypoglycemia.

Published
2020
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29. Continuous subcutaneous insulin infusion reduces maternal and neonatal risk in pregnant women with type 1 diabetes: An observational cohort study of 122 pregnancies

Author

Silvia Galliani, Giorgia Cavalli, Cristiana Scaranna, Anna Maria Corsi, Giuseppe Lepore, Mascia Albizzi, Rosalia Bellante, G. Mangili, Alessandro Roberto Dodesini, Elena Ciriello, Roberto Trevisan, Dodesini, A, Cavalli, G, Ciriello, E, Lepore, G, Corsi, A, Scaranna, C, Bellante, R, Albizzi, M, Galliani, S, Mangili, G, and Trevisan, R

Subjects
Adult, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Infusions, Subcutaneous, Injections, Cohort Studies, Insulin Infusion Systems, Pregnancy, Diabetes mellitus, continuous subcutaneous insulin infusion, large for gestational age, multiple daily injections, pregnancy, type 1 diabetes, medicine, Humans, Hypoglycemic Agents, Insulin, Aged, Type 1 diabetes, business.industry, Obstetrics, Infant, Newborn, medicine.disease, Subcutaneous insulin, Diabetes Mellitus, Type 1, Treatment Outcome, Female, business, Cohort study
Published
2020
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30. Sex differences in food choices, adherence to dietary recommendations and plasma lipid profile in type 2 diabetes - The TOSCA.IT study

Author

Christian Caselli, M. C. Ruffo, Fabrizio Cappellini, Maria Masulli, P. Di Bartolo, Carmela Giordano, Giovanni Sartore, G. Citro, L. Corsi, Stefano Signorini, Giorgio Clemente, G. Mancastroppa, M. Mori, Elena Ceccarelli, Raffaella Buzzetti, Roberto Anichini, Olga Vaccaro, Gabriele Perriello, A. C. Babini, Vittorio Krogh, L. Tonutti, Sergio Giuseppe Longhitano, Laura Salvi, Carlo Giorda, Agostino Consoli, R. Carpinteri, M. E. Rinaldi, Chiara Mazzucchelli, A. Zogheri, Massimo Boemi, A. De Gregorio, Clarissa Zamboni, Monia Garofolo, S. Cocozza, Enzo Bonora, Veronica Montani, C. Scaranna, Giovanna Riccardi, Lucia Fontana, G. Di Cianni, Mauro Cignarelli, C. Iovine, Sara Grioni, Martina Vitale, Vitale, Marilena, Masulli, Maria, Cocozza, Sara, Anichini, R., Babini, A. C., Boemi, M., Bonora, E., Buzzetti, R., Carpinteri, R., Caselli, C., Ceccarelli, E., Cignarelli, M., Citro, G., Clemente, G., Consoli, A., Corsi, L., De Gregorio, A., Di Bartolo, P., Di Cianni, G., Fontana, L., Garofolo, M., Giorda, C. B., Giordano, C., Grioni, S., Iovine, Ciro, Longhitano, S., Mancastroppa, G., Mazzucchelli, C., Montani, V., Mori, M., Perriello, G., Rinaldi, M. E., Ruffo, M. C., Salvi, L., Sartore, G., Scaranna, C., Tonutti, L., Zamboni, C., Zogheri, A., Krogh, V., Cappellini, F., Signorini, S., Riccardi, Gabriele, and Vaccaro, Olga

Subjects
Male, Time Factors, Healthy Diet, Endocrinology, Diabetes and Metabolism, Saturated fat, Medicine (miscellaneous), Type 2 diabetes, Cardiovascular risk factors, Diabetes, Dietary habits, Men, Nutritional recommendations, Sex differences, Women, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, Diabete, Recommended Dietary Allowances, Choice Behavior, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Risk Factors, Aged, Biomarkers, Diabetes Mellitus, Type 2, Female, Food Preferences, Humans, Italy, Lipids, Middle Aged, Nutrition Assessment, Sex Factors, Surveys and Questionnaires, Treatment Outcome, Feeding Behavior, Patient Compliance, Food choice, Medicine, 030212 general & internal medicine, Food science, Diabetes and Metabolism, Saturated fatty acid, Diet, Healthy, Type 2, 030209 endocrinology & metabolism, Added sugar, Dietary habit, 03 medical and health sciences, Diabetes mellitus, Diabetes Mellitus, Healthy, business.industry, Unsaturated fat, Nutritional recommendation, Sex difference, medicine.disease, Diet, chemistry, Glycated hemoglobin, business
Abstract

Background and aims: Diabetic women have a more adverse plasma lipid profile than men. Sex differences in dietary habits may play a role, but are little investigated. The study evaluates the quality of diet, adherence to the nutritional recommendations of the Diabetes and Nutrition Study Group and their relation with plasma lipid in men and women with diabetes. Methods and results: We studied 2573 people, aged 50e75, enrolled in the TOSCA.IT study (clinicaltrials.gov; NCT00700856). Plasma lipids were measured centrally. Diet was assessed with a semi-quantitative food frequency questionnaire.Women had a more adverse plasma lipid profile than men.Women consumed significantly more legumes, vegetables, fruits, eggs, milk, vegetable oils, and added sugar, whereas men consumed more starchy foods, soft drinks and alcoholic beverages. This stands for a higher proportion (%) of energy intake from saturated fat and added sugar (12.0 2.4 vs 11.5 2.5 and 3.4 3.2 vs 2.3 3.2, P < 0.04), and a higher intake of fiber (11.2 2.8 vs 10.4 2.6 g/1000 Kcal/day) in women. Adherence to the recommendations for saturated fat and fiber consumption was associated with significantly lower LDL-cholesterol regardless of sex. Adherence to the recommendations for added sugars was associated with significantly lower triglycerides and higher HDL-cholesterol in men and women. Conclusions: Men and women with diabetes show significant differences in adherence to nutritional recommendations, but sex differences in plasma lipid profile are unlikely to be explained by nutritional factors. Adherence to the nutritional recommendations is associated with a better plasma lipid profile regardless of sex, thus reinforcing the importance of substituting saturated for unsaturated fat sources, increasing fiber and reducing added sugar intake.

Published
2016
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31. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M., Masulli, M., Rivellese, A. A., Bonora, E., Cappellini, F., Nicolucci, Andrea, Squatrito, S., Antenucci, D., Barrea, A., Bianchi, C., Bianchini, F., Fontana, L., Fornengo, P., Giorgino, F., Gnasso, A., Mannucci, E., Mazzotti, A., Nappo, R., Palena, A. P., Pata, P., Perriello, G., Potenziani, S., Radin, R., Ricci, L., Romeo, F., Santini, C., Scarponi, M., Serra, Riccardo, Timi, A., Turco, A. A., Vedovato, M., Zavaroni, D., Grioni, S., Riccardi, G., Vaccaro, O., Rivellese, Angela Albarosa, Cocozza, Sara, Auciello, Stefania, Turco, Anna Amelia, Bonora, Enzo, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Tomasetto, Elena, Perriello, Gabriele, Timi, Alessia, Squatrito, Sebastiano, Sinagra, Tiziana, Longhitano, Sara, Tropea, Vanessa, Ballardini, Giorgio, Babini, Anna Carla, Ripani, Raffaella, Gregori, Giovanna, Dolci, Maria, Bruselli, Laura, Salutini, Isabella, Mori, Mary, Baccetti, Fabio, Lapolla, Annunziata, Sartore, Giovanni, Burlina, Silvia, Chilelli, Nino Cristiano, Buzzetti, Raffaella, Venditti, Chiara, Potenziani, Stella, Carlone, Angela, Galluzzoâ€&nbsp, Aldo, Giordano, Carla, Torregrossa, Vittoria, Corsi, Laura, Cuneo, Giacomo, Corsi, Simona, Tizio, Biagio, Clemente, Gennaro, Citro, Giuseppe, Natale, Maria, Salvatore, Vita, Di Cianni, Graziano, Lacaria, Emilia, Russo, Laura, Iannarelli, Rossella, de Gregorio, Antonella, Sciarretta, Filomena, D’Andrea, Settimio, Montani, Valeria, Cannarsa, Emanuela, Dolcetti, Katia, Cordera, Renzo, Bonabello, Laura Affinito, Mazzucchelli, Chiara, Giorda, Carlo Bruno, Romeo, Francesco, Bonetto, Caterina, Antenucci, Daniela, Baldassarre, Maria Pompea Antonia, Iovine, Ciro, Nappo, Rossella, Ciano, Ornella, Dall’Aglio, Elisabetta, Mancastroppa, Giovanni, Grimaldi, Franco, Tonutti, Laura, Boemi, Massimo, D’Angelo, Federica, Leotta, Sergio, Fontana, Lucia, Lauro, Davide, Rinaldi, Maria Elena, Cignarelli, Mauro, la Macchia, Olga, Fariello, Stefania, Tomasi, Franco, Zamboni, Chiara, Dozio, Nicoletta, Trevisan, Roberto, Scaranna, Cristiana, Del Prato, Stefano, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Pugliese, Giuseppe, Salvi, Laura, Rangel, Graziela, Vitale, Martina, Anichini, Roberto, Tedeschi, Anna, Corsini, Elisa, Cucinotta, Domenico, Di Benedetto, Antonino, Giunta, Loretta, Ruffo, Maria Concetta, Bossi, Antonio Carlo, Carpinter, Rita, Dotta, Francesco, Ceccarelli, Elena, Bartolo, Paolo Di, Caselli, Chiara, Luberto, Alessandra, Santini, Costanza, Mazzotti, Arianna, Calbucci, Giovanni, Consoli, Agostino, Ginestra, Federica, Calabrese, Maria, Zogheri, Alessia, Ricci, Lucia, Giorgino, Francesco, Laviola, Luigi, Ippolito, Claudia, Tarantino, Lucia, Avogaro, Angelo, Vedovato, Monica, Gnasso, Agostino, Carallo, Claudio, Scicchitano, Caterina, Zavaroni, Donatella, Livraga, Stefania, Perin, Paolo Cavallo, Forrnengo, Paolo, Prinzis, Tania, de Cosmo, Salvatore, Palena, Antonio Pio, Bacci, Simonetta, Mannucci, Edoardo, Lamanna, Caterina, Pata, Pietro, Lettina, Gabriele, Aiello, Antimo, Barrea, Angelina, Lalli, Carlo, Scarponi, Maura, Franzetti, Ivano, Radin, Raffaella, Serra, Rosalia, Petrachi, Francesca, Asprino, Vincenzo, Capra, Claudio, Forte, Elisa, Reggiani, Giulio Marchesini, Forlani, Gabriele, Montesi, Luca, Mazzella, Natalia, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Auletta, Pasquale, Petraroli, Ettore, Capobianco, Giuseppe, Romano, Geremia, Cutolo, Michele, de Simone, Giosetta, Caiazzo, Gennaro, Nunziata, Peppe, Sorrentino, Susy, Amelia, Umberto, Calatola, Pasqualino, Capuano, Gelsomina, Vitale, M, Masulli, M, Rivellese, AA, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo,P, Giorgino, F, Gnasso, A, Mannucci, Mazzotti, A, Nappo, R, Palena, AP, Pata, P,Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, AA, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, TOSCA.IT Study Group., Giordano, C., Rivellese, Aa, Fornengo, P, Mannucci, E, Mazzotti, A, Nappo, R, Palena, Ap, Pata, P, Perriello, G, Turco, Aa, Tosc, A. IT Study Group., Rivellese, A, Palena, A, Turco, A, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, and Capuano, G

Subjects
0301 basic medicine, Male, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Aged, Antioxidants, Beverages, Cinnamates, Cohort Studies, Cross-Sectional Studies, Databases, Factual, Diabetes Mellitus, Type 2, Female, Flavonoids, Fruit, Glycosides, Humans, Italy, Male, Middle Aged, Nutritive Value, Phenols, Polyphenols, Diet, Diabetic, Diet, Healthy, Patient Compliance, Settore MED/09 - Medicina Interna, Databases, Factual, Cross-sectional study, Medicine (miscellaneous), Type 2 diabetes, Diabete, Antioxidants, Settore MED/13 - Endocrinologia, Food group, Cohort Studies, 0302 clinical medicine, Diet, Diabetic, Medicine, Food science, Glycosides, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Nutrition and Dietetics, Phenolic acid, food and beverages, Middle Aged, Polyphenols, Flavonoids, Phenolic acids, Diabetes, Food groups, Diet, Age, BMI, Geographical area, Intake, TOSCA.IT study, Italy, Tosca,Age,BMI,Diabetes,Diet,Flavonoids,Food groups,Geographical area,Intake,Phenolic acids,Polyphenols,TOSCA.IT study, Cohort, Female, Diet, Healthy, Nutritive Value, Cohort study, Polyphenol, 030209 endocrinology & metabolism, Beverages, 03 medical and health sciences, Phenols, Diabetes mellitus, Humans, Aged, 030109 nutrition & dietetics, business.industry, Anthropometry, medicine.disease, Tosca, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Cinnamates, Fruit, Flavonoid, Patient Compliance, business
Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes. © 2016 Springer-Verlag Berlin Heidelberg

Published
2016
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32. Studio della correlazione tra uricemia e variabili metaboliche nella popolazione generale. Dati dello studio Pamela

Author

SCARANNA, CRISTIANA, Scaranna, C, and GRASSI, GUIDO

Subjects
acido urico, circonferenza vita, obesità, MED/09 - MEDICINA INTERNA
Abstract

SCOPI: Lo scopo del nostro studio è valutare la rilevanza clinica del dosaggio dell'uricemia in soggetti in sovrappeso appartenenti ad una popolazione generale urbana del Nord Italia. Tale scopo è stato perseguito mediante l'analisi dei seguenti due aspetti: studio della correlazione tra i livelli di acido urico e i parametri metabolici; valore predittivo dell’uricemia nei confronti della mortalità totale e cardiovascolare in soggetti in sovrappeso o caratterizzati da incremento del girovita. MATERIALI E METODI: per il nostro studio abbiamo analizzato i dati ricavati dagli accertamenti eseguiti su 2045 soggetti che hanno preso parte allo studio Pamela. Uno studio condotto nell’area della città di Monza tra il 1990 e il 1993 fino al 2009 per un follow up complessivo di 17 anni. Ad ogni soggetto è stato prelevato un campione di sangue per l’analisi della glicemia, colesterolemia totale e frazionata, trigliceridemia, dell’emoglobina glicosilata e dell’acido urico sierico. E' stata effettuata la misurazione dell'indice di massa corporea (BMI) mediante formula k/m². L'adiposità addominale è stata misurata attraverso la circonferenza vita (CV). RISULTATI: 1033 soggetti (51.7%) con BMI ≥ 25 k/m² e 840 soggetti (43.3%) con circonferenza vita ≥ 80 cm (F) - 94 cm (M) sono stati selezionati per la nostra analisi finale. Ulteriori analisi sono state effettuate in due sottopopolazioni costituite da 271 soggetti obesi (BMI ≥ 30 K/m²) e 383 soggetti con girovita francamente aumentato (CV ≥ 88 (F) cm / 102 (M) cm). I soggetti obesi (BMI ≥ 30 k/m²) ed in sovrappeso (BMI ≥ 25 k/m²) presentavano livelli medi di acido urico significativamente più elevati rispetto al resto della popolazione. Allo stesso modo i soggetti con girovita aumentato (CV ≥ 80 cm (F) - 94 cm (M) e francamente elevato (CV ≥ 88 (F) / 102 (M) cm) avevano livelli medi di acido urico significativamente più elevati rispetto al resto della popolazione. I dati conservavano la loro significatività statistica anche dopo correzione per età e genere (p

Published
2013

33. Bolus calculator improves long-term metabolic control and reduces glucose variability in pump-treated patients with Type 1 diabetes

Author

C. Scaranna, I. Nosari, Giuseppe Lepore, R. Trevisan, Anna Maria Corsi, Alessandro Roberto Dodesini, Lepore, G, Dodesini, A, Nosari, I, Scaranna, C, Corsi, A, and Trevisan, R

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), Infusions, Subcutaneous, Automation, Bolus (medicine), Insulin Infusion Systems, Software Design, Internal medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Drug Dosage Calculations, Glycated Hemoglobin, Type 1 diabetes, Nutrition and Dietetics, business.industry, Blood Glucose Self-Monitoring, Equipment Design, type 1 diabetes, glucose variability, bolus calculator, Middle Aged, medicine.disease, Hypoglycemia, Diabetes Mellitus, Type 1, Treatment Outcome, Metabolic control analysis, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Biomarkers
Published
2012

34. Maternal glycaemic levels are associated with incidence of large for gestational age neonates in type 1 diabetic women in pregnancy.

Author

Dodesini AR, Ciriello E, Bellante R, Corsi A, Giunta MR, Scaranna C, Albizzi M, Lepore G, and Trevisan R

Subjects
Humans, Female, Pregnancy, Infant, Newborn, Risk Factors, Adult, Incidence, Risk Assessment, Glycated Hemoglobin metabolism, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 1 epidemiology, Blood Glucose metabolism, Fetal Macrosomia epidemiology, Fetal Macrosomia diagnosis, Pregnancy in Diabetics blood, Pregnancy in Diabetics epidemiology, Pregnancy in Diabetics diagnosis, Biomarkers blood, Birth Weight, Gestational Age
Published
2024
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35. Development of a New Model of Insulin Sensitivity in Patients With Type 2 Diabetes and Association With Mortality.

Author

Ciardullo S, Dodesini AR, Lepore G, Corsi A, Scaranna C, Perseghin G, and Trevisan R

Subjects
Humans, Blood Glucose, Nutrition Surveys, Cardiovascular Diseases complications, Diabetes Mellitus, Type 2, Insulin Resistance physiology
Abstract

Context: Despite being one of the major drivers of diabetes incidence, the degree of insulin resistance in patients with type 2 diabetes (T2D) is not usually evaluated in clinical practice or in large epidemiologic studies., Objective: To identify a model of insulin sensitivity using widely available clinical and laboratory parameters in patients with T2D and evaluate its association with all-cause and cardiovascular mortality., Methods: One hundred forty patients with T2D underwent a euglycemic hyperinsulinemic clamp to measure total body glucose disposal rate (mg kg-1 minute-1). We used demographic, clinical, and common laboratory parameters to estimate insulin sensitivity (IS) via stepwise linear regression on 85 patients (training cohort) and validated it in the remaining 55 (validation cohort). The identified equation was then applied to 3553 patients with T2D from the 1999-2010 cycles of the National Health and Nutrition Examination Survey (NHANES) to evaluate its association with all-cause and cardiovascular mortality up to December 2015., Results: The best model included triglycerides, gamma glutamyl transpeptidase, albumin excretion rate, and body mass index. The identified IS score correlated well with the clamp-derived glucose disposal rate in both the training (r = 0.77, P < .001) and the validation (r = 0.74, P < .001) cohorts. In the NHANES cohort, after a median follow-up of 8.3 years, 1054 patients died, 265 of cardiovascular causes. In a multivariable Cox proportional hazard model adjusted for age, sex, race-ethnicity, education, cigarette smoke, total cholesterol, chronic kidney disease, blood pressure, prevalent cardiovascular disease, and alcohol consumption, a higher estimated IS was associated with a lower risk of both all-cause and cardiovascular mortality., Conclusion: We propose a new model of IS in patients with T2D based on readily available clinical and laboratory data. Its potential applications are in both diagnosis as well as prognostication., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2024
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36. Advanced Hybrid Closed-Loop System Achieves and Maintains Recommended Time in Range Levels for Up To 2 Years: Predictors of Best Efficacy.

Author

Lepore G, Borella ND, Castagna G, Ippolito S, Bonfadini S, Corsi A, Scaranna C, Dodesini AR, Bellante R, and Trevisan R

Subjects
Adult, Male, Humans, Middle Aged, Blood Glucose Self-Monitoring, Retrospective Studies, Insulin therapeutic use, Insulin, Regular, Human, Hypoglycemic Agents therapeutic use, Insulin Infusion Systems, Blood Glucose, Diabetes Mellitus, Type 1 drug therapy
Abstract

Aim: To evaluate the long-term efficacy, up to 2 years, of an advanced hybrid closed-loop (AHCL) system and to assess predictors of best results of the therapy. Methods: We retrospectively evaluated 296 adults with type 1 diabetes mellitus [mean age 42.8 ± 16.5 years, men 42.9%, duration of diabetes 22.5 ± 12.8 years, body mass index 24.9 ± 4.7 kg/m 2 , baseline glycated hemoglobin (HbA 1c ) 63.4 ± 12.2 mmol/mol (8.0 ± 1.1%) ] who used the MiniMed™ 780G system. Demographic and clinical data were recorded. Continuous glucose monitoring (CGM)-derived metrics and insulin requirement were analyzed from the 4 weeks before and from every quarter after the switch to the AHCL system. Results: In the first quarter of AHCL treatment, all CGM metrics improved. Time in range (TIR) increased from 58.1 ± 17.5% to 70.3 ± 9.5% ( P  < 0.0001). The improvement lasted for up to 2 years of observation regardless of previous insulin therapies. Throughout the period of observation, 53.4% of participants achieved mean TIR >70%, 92.6% mean time below range <4%, and 46% mean glucose management indicator <53 mmol/mol (7.0%). At univariable logistic regression older age, lower baseline HbA 1c and insulin requirement were associated with mean TIR >70%. At multivariable analysis, lower HbA 1c remained independently associated with a better glycemic control. However, mean TIR increased more in participants with a higher baseline HbA 1c . Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to 24 months along with a low risk for hypoglycemia, confirming the safety of the system. Lower baseline HbA 1c was the main predictor of better efficacy of therapy, although higher baseline HbA 1c was associated with the greatest improvement in mean TIR.

Published
2024
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38. Switching to the Minimed™ 780G system achieves clinical targets for CGM in adults with type 1 diabetes regardless of previous insulin strategy and baseline glucose control.

Author

Lepore G, Rossini A, Bellante R, Corsi A, Scaranna C, Dodesini AR, and Trevisan R

Subjects
Adult, Blood Glucose, Blood Glucose Self-Monitoring, Female, Humans, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Insulin Infusion Systems, Male, Middle Aged, Retrospective Studies, Diabetes Mellitus, Type 1 drug therapy
Abstract

Aims: Advanced hybrid closed-loop (AHCL) systems represent the latest introduction in the treatment of type 1 diabetes (T1DM). Randomized controlled trials and real-world evidence studies showed that AHCL systems are a safe and effective insulin management strategy. Aim of this retrospective, single-center, real-life study was to evaluate the effect on metabolic control, evaluated by continuous glucose monitoring (CGM) metrics, of the switch from four available insulin strategies to an AHCL system in adult patients with type 1 diabetes., Methods: A total of 102 patients with T1DM (mean age 42.1 ± 16.3 years, males/females 47/55, duration of diabetes 21.4 ± 13.3 years, BMI 24.4 ± 4.5 kg/m 2 , HbA 1c 59.9 ± 9.6 mmol/mol or 7.6 ± 0.9%), treated with four different insulin therapies [multiple daily insulin (MDI) therapy, continuous subcutaneous insulin infusion (CSII), sensor-augmented pump (SAP) with predictive low-glucose suspend (PLGS), and hybrid closed loop (HCL) system] were evaluated before hand, two months and six months after switching to an AHCL (Minimed™ 780G system, Medtronic, Northridge, CA) system., Results: Two months after the switch, mean GCM metrics improved in all four treatment groups. Six months after the switch, the participants of all four groups achieved a mean GMI < 53 mmol/mol, TIR > 70%, TBR < 4%, and CV < 36%, which is recommended by the ADA Standard of Medical Care in Diabetes 2022, including the MDI group with worse baseline glycemic control., Conclusions: Switching to an AHCL leads to a rapid improvement in glycemic control lasting for up to six months independently of previous insulin treatment and baseline conditions., (© 2022. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Published
2022
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39. Dapagliflozin acutely improves kidney function in type 2 diabetes mellitus. The PRECARE study.

Author

Lazzaroni E, Lunati ME, Montefusco L, Pastore I, Chebat E, Cimino V, Morpurgo PS, Muratori M, Plebani L, Bolla A, Rossi A, Vallone L, Gandolfi A, Tinari C, D'Addio F, Nasr MB, Loretelli C, Scaranna C, Bellante R, Manfrini R, Muratori F, Franzetti I, Orsi E, Gazzaruso C, Ghelardi R, Desenzani P, Genovese S, Girelli A, Folli F, Berra C, and Fiorina P

Subjects
Albuminuria drug therapy, Benzhydryl Compounds adverse effects, Blood Glucose, Glucosides, Humans, Kidney, Diabetes Mellitus, Type 2, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
Abstract

Dapagliflozin has been demonstrated to improve glycemic control, blood pressure, and body weight in type 2 diabetes mellitus (T2D); indeed, it can also reduce the risk of progression to renal failure, of hospitalization for heart failure and of cardiovascular death. We aim to investigate the acute effect of Dapagliflozin on kidney function in the common clinical practice in T2D. This is a study including 1402 patients with T2D recruited from 11 centers in Lombardia, Italy, who were evaluated at baseline and after 6 months of treatment with Dapagliflozin 10 mg per day. The primary outcome of the study was the change in HbA1c, while the secondary outcomes were modification of weight, BMI, systolic and diastolic pressure, creatinine, eGFR and albuminuria status. After 24 weeks of treatment with Dapagliflozin, a reduction in Hb1Ac was observed (-0.6 ± 1.8%) as well as in BMI (-1.5 ± 5.2 kg/m 2 ). Statistically significant changes were also found for systolic and diastolic blood pressure, cholesterol and triglycerides. Interestingly, a statistically significant acute improvement of kidney function was evident. Our analyses confirm the beneficial effects of dapagliflozin after 6 months of therapy, with improvements of glycemic and lipid profiles, blood pressure, BMI. Finally, an acute positive effect on albuminuria and KIDGO classes was observed during a 6 months treatment with dapagliflozin in patients with T2D., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Published
2022
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40. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study.

Author

Solerte SB, D'Addio F, Trevisan R, Lovati E, Rossi A, Pastore I, Dell'Acqua M, Ippolito E, Scaranna C, Bellante R, Galliani S, Dodesini AR, Lepore G, Geni F, Fiorina RM, Catena E, Corsico A, Colombo R, Mirani M, De Riva C, Oleandri SE, Abdi R, Bonventre JV, Rusconi S, Folli F, Di Sabatino A, Zuccotti G, Galli M, and Fiorina P

Subjects
Betacoronavirus, COVID-19, Hospitalization, Humans, Italy, Retrospective Studies, SARS-CoV-2, Sitagliptin Phosphate therapeutic use, Coronavirus, Coronavirus Infections, Diabetes Mellitus, Type 2 drug therapy, Pandemics, Pneumonia, Viral
Abstract

Objective: Poor outcomes have been reported in patients with type 2 diabetes and coronavirus disease 2019 (COVID-19); thus, it is mandatory to explore novel therapeutic approaches for this population., Research Design and Methods: In a multicenter, case-control, retrospective, observational study, sitagliptin, an oral and highly selective dipeptidyl peptidase 4 inhibitor, was added to standard of care (e.g., insulin administration) at the time of hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19. Every center also recruited at a 1:1 ratio untreated control subjects matched for age and sex. All patients had pneumonia and exhibited oxygen saturation <95% when breathing ambient air or when receiving oxygen support. The primary end points were discharge from the hospital/death and improvement of clinical outcomes, defined as an increase in at least two points on a seven-category modified ordinal scale. Data were collected retrospectively from patients receiving sitagliptin from 1 March through 30 April 2020., Results: Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted in Northern Italy hospitals included in this study, 169 were on sitagliptin, while 169 were on standard of care. Treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs. 37% of deceased patients; hazard ratio 0.44 [95% CI 0.29-0.66]; P = 0.0001), with an improvement in clinical outcomes (60% vs. 38% of improved patients; P = 0.0001) and with a greater number of hospital discharges (120 vs. 89 of discharged patients; P = 0.0008) compared with patients receiving standard of care, respectively., Conclusions: In this multicenter, case-control, retrospective, observational study of patients with type 2 diabetes admitted to the hospital for COVID-19, sitagliptin treatment at the time of hospitalization was associated with reduced mortality and improved clinical outcomes as compared with standard-of-care treatment. The effects of sitagliptin in patients with type 2 diabetes and COVID-19 should be confirmed in an ongoing randomized, placebo-controlled trial., (© 2020 by the American Diabetes Association.)

Published
2020
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41. ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide.

Author

Bossi AC, De Mori V, Scaranna C, Veronesi G, and Lepore G

Abstract

Introduction: Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-primary outcomes) for up to 24 months in the real-life setting in consecutive outpatients with type 2 diabetes (T2D) who initiated dulaglutide. Co-secondary outcomes were durability of treatment effects on both glycated hemoglobin (HbA1c) and body weight., Methods: Overall, 1584 subjects (696 women, 888 men) with T2D (mean age [± standard deviation] 61.7 ± 10.2 years; mean T2D duration 9.9 ± 6.9 years) were treated with dulaglutide (0.75 or 1.5 mg once weekly) between April 2016 and December 2019., Results: A total of 1130 patients completed 12 months of follow-up, while 170 patients interrupted treatment before the 12-month endpoint. At 12 months, average HbA1c and average fasting plasma glucose (FPG) were significantly lower compared to baseline levels (- 10 mmol/mol and - 24.9 mg/dL, respectively), as were body weight (- 3.4 kg) and waist circumference (- 3.3 cm) values (all p < 0.0001). Among subjects that completed 24 months of follow-up (n = 270), the rapid decline in HbA1c and FPG values in the first 12 months was followed by stabilization in the following 12 months (p value for 12-24 months trend: 0.4 and 0.6, respectively)., Conclusions: Dulaglutide is an effective drug for the treatment of T2D that is administered once weekly using a simple auto-injector device. Real-life data confirm the observations in randomized controlled trials that persistent treatment with dulaglutide may help patients with T2D achieve an improvement in some metabolic features and in body weight. It is important that the benefits of therapy with dulaglutide, i.e., the effects of the "glycemic" and the so-called "extra-glycemic" actions of GLP-1RAs, are supported by diabetes care teams emphasizing the need for patients to maintain a healthy lifestyle.

Published
2020
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42. Continuous subcutaneous insulin infusion reduces maternal and neonatal risk in pregnant women with type 1 diabetes: An observational cohort study of 122 pregnancies.

Author

Dodesini AR, Cavalli G, Ciriello E, Lepore G, Corsi A, Scaranna C, Bellante R, Albizzi M, Galliani S, Mangili G, and Trevisan R

Subjects
Adult, Aged, Cohort Studies, Female, Humans, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Infant, Newborn, Infusions, Subcutaneous, Injections, Insulin administration & dosage, Insulin Infusion Systems, Pregnancy, Treatment Outcome, Diabetes Mellitus, Type 1 drug therapy, Insulin therapeutic use
Published
2020
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43. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case-Control Study.

Author

Lepore G, Scaranna C, Corsi A, Dodesini AR, and Trevisan R

Subjects
Adult, Blood Glucose analysis, Blood Glucose Self-Monitoring, Case-Control Studies, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 complications, Female, Humans, Hypoglycemia etiology, Hypoglycemia prevention & control, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Diabetes Mellitus, Type 1 drug therapy, Glycemic Control instrumentation, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems
Abstract

There are no data whether hybrid closed-loop (HCL) systems are superior to sensor-augmented pump (SAP) therapy with predictive low glucose suspend (PLGS) feature in improving glucose control. Aim of our study was to evaluate the effect on metabolic control and glucose variability of the switch from SAP therapy with PLGS to a HCL system in type 1 diabetic individuals. Forty adults with type 1 diabetes, who had been using SAP therapy with PLGS feature (Minimed 640G; Medtronic, Northridge, CA) for at least 12 months were evaluated in a 6-month case-control observational retrospective study. Twenty subjects who consecutively switched from Minimed 640G to a HCL system (Minimed 670G; Medtronic) (670G group) were compared with a control group consisting of 20 subjects who continued with the MiniMed 640G pump (640G group) matched for age, gender, and HbA 1c . At the end of the study there was a significant reduction in average HbA 1c levels (-4.9 ± 6.4 mmol/mol [-0.4% ± 0.6%], P  < 0.01), sensor glucose concentrations (-15.4 ± 17.7 mg/dL, P  < 0.005), coefficient of variation of sensor glucose concentrations (-3.8% ± 3.6%, P  < 0.01), percentage time spent in both hyperglycemic range 181-250 mg/dL (-5.1% ± 4.5%, P  < 0.05), and >250 mg/dL (-6.1% ± 6.9%, P  < 0.05) in the 670G group, whereas they remained unchanged in the 640G group. Percentage of time spent in euglycemic range significantly increased (11.6% ± 8.3%, P  < 0.005) only in the 670G group. There was no change in time spent in hypoglycemic range in both groups. In adults with type 1 diabetes, switching from a 640G to a 670G system significantly improved glucose control and reduced glucose variability, thus reaching in most cases the recommended targets for time spent in euglycemic and hyperglycemic ranges without increasing the risk of hypoglycemia.

Published
2020
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44. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial.

Author

Vaccaro O, Masulli M, Nicolucci A, Bonora E, Del Prato S, Maggioni AP, Rivellese AA, Squatrito S, Giorda CB, Sesti G, Mocarelli P, Lucisano G, Sacco M, Signorini S, Cappellini F, Perriello G, Babini AC, Lapolla A, Gregori G, Giordano C, Corsi L, Buzzetti R, Clemente G, Di Cianni G, Iannarelli R, Cordera R, La Macchia O, Zamboni C, Scaranna C, Boemi M, Iovine C, Lauro D, Leotta S, Dall'Aglio E, Cannarsa E, Tonutti L, Pugliese G, Bossi AC, Anichini R, Dotta F, Di Benedetto A, Citro G, Antenucci D, Ricci L, Giorgino F, Santini C, Gnasso A, De Cosmo S, Zavaroni D, Vedovato M, Consoli A, Calabrese M, di Bartolo P, Fornengo P, and Riccardi G

Subjects
Aged, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Diabetes Mellitus, Type 2 epidemiology, Drug Therapy, Combination, Female, Humans, Incidence, Male, Middle Aged, Pioglitazone, Treatment Outcome, Cardiovascular Diseases drug therapy, Diabetes Mellitus, Type 2 complications, Hypoglycemic Agents therapeutic use, Metformin therapeutic use, Sulfonylurea Compounds therapeutic use, Thiazolidinediones therapeutic use
Abstract

Background: The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes., Methods: TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50-75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2-3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15-45 mg) or a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856., Findings: Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74-1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p<0·0001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups., Interpretation: In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events., Funding: Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Published
2017
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