141 results on '"Maddaloni E"'
Search Results
2. IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study
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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
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Type  ,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.
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- 2022
3. Serum chitotriosidase in postmenopausal women with severe osteoporosis
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Musumeci, M., Palermo, A., D’Onofrio, L., Vadalà, G., Greto, V., Di Stasio, E., Maddaloni, E., Di Rosa, M., Tibullo, D., Silvia, A., Napoli, N., Denaro, V., and Manfrini, S.
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- 2016
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4. Ischemic and bleeding risk by type 2 diabetes clusters in patients with acute coronary syndrome
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Cavallari, I., Maddaloni, E., Gragnano, F., Patti, G., Antonucci, E., Calabro, P., Cirillo, P., Gresele, P., Palareti, G., Pengo, V., Pignatelli, P., Marcucci, R., Moscarella, E., Cesaro, A., Grossi, G., Berteotti, M., De Rosa, G., Taglialatela, V., Digitale, L., Denas, G., Pastori, D., del Pinto, M., Fierro, T., Cavallari, Ilaria, Maddaloni, Ernesto, Gragnano, Felice, Patti, Giuseppe, Antonucci, Emilia, Calabrò, Paolo, Cirillo, Plinio, Gresele, Paolo, Palareti, Gualtiero, Pengo, Vittorio, Pignatelli, Pasquale, and Marcucci, Rossella
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Male ,Registrie ,Acute coronary syndrome ,medicine.medical_specialty ,medicine.medical_treatment ,Hemorrhage ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Diabete ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Major cardiovascular event ,Diabetes mellitus ,Internal medicine ,Internal Medicine ,Humans ,Insulin ,Medicine ,Prospective Studies ,Registries ,030212 general & internal medicine ,Proportional Hazards Models ,Aged ,business.industry ,Major cardiovascular events ,Incidence ,Bleeding ,Type 2 Diabetes Mellitus ,Middle Aged ,medicine.disease ,Clopidogrel ,acute coronary syndromes ,bleeding ,diabetes ,insulin ,major cardiovascular events ,Prospective Studie ,Diabetes Mellitus, Type 2 ,Italy ,Proportional Hazards Model ,Emergency Medicine ,Female ,business ,Ticagrelor ,Mace ,Human ,medicine.drug - Abstract
The risk of ischemic events carried by different clusters of type 2 diabetes mellitus (DM) in the setting of secondary prevention is not definite and the association between DM and bleeding complications is controversial. We explored these issues in the START-ANTIPLATELET, a multicenter Italian registry including acute coronary syndrome (ACS) patients. Study outcome was 1-year incidence of the net composite endpoint including major adverse cardiovascular events (MACE) or any bleeding and its individual components across different DM strata (no DM, DM with or without insulin). Out of 951 patients, 20.0% had diabetes not on insulin and 2.5% had diabetes on insulin. The rate of the net composite endpoint was highest in patients receiving insulin (39.4 per 100 person-years vs 11.7 in diabetic patients not on insulin vs 14.0 in those without DM; p = 0.007). In DM, the higher risk of MACE was regardless of insulin use (p = 0.36). Conversely, the increase in bleeding complications was limited to patients on insulin (Hazard Ratio 2.31, 95% CI 0.93-5.71 vs no DM; p = 0.0105 across DM strata). On top of aspirin, the rates of the net composite endpoint were similar with ticagrelor/prasugrel or clopidogrel irrespective of DM status (p for interaction 0.63). In conclusion, in ACS patients, type 2 DM enhances the risk of MACE regardless of the DM cluster, whereas the propensity to bleeding related to DM seems confined to insulin-treated patients.
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- 2021
5. Association between platelet reactivity and long-term bleeding complications following percutaneous coronary intervention in patients with and without diabetes
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Cavallari, I, primary, Patti, G, additional, Maddaloni, E, additional, Veneziano, F, additional, Mangiacapra, F, additional, Ricottini, E, additional, Ussia, G P, additional, and Grigioni, F, additional
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- 2021
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6. In vivo corneal confocal microscopy as a novel non-invasive tool to investigate cardiac autonomic neuropathy in Type 1 diabetes
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Maddaloni, E., Sabatino, F., Del Toro, R., Crugliano, S., Grande, S., Pantano, Lauria A., Maurizi, A. R., Palermo, A., Bonini, S., Pozzilli, P., and Manfrini, S.
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- 2015
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7. Cardiometabolic multimorbidity is associated with a worse Covid-19 prognosis than individual cardiometabolic risk factors: a multicentre retrospective study (CoViDiab II)
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Maddaloni, E., D'Onofrio, L., Alessandri, F., Mignogna, C., Leto, G., Pascarella, G., Mezzaroma, I., Lichtner, M., Pozzilli, P., Agro, F. E., Rocco, M., Pugliese, F., Lenzi, A., Holman, R. R., Mastroianni, C. M., Buzzetti, R., Ajassa, C., Alban, R., Alessi, F., Aronica, R., Belvisi, V., Candy, M., Caputi, A., Carrara, A., Casali, E., Cavallari, E. N., Ceccarelli, G., Celani, L., Ciardi, M. R., Coraggio, L., Curtolo, A., D'Agostino, C., D'Ettorre, G., De Giorgi, F., De Girolamo, G., Filippi, V., Gnessi, L., Luordi, C., Moretti, C., Recchia, G., Ridolfi, M., Romani, F. E., Russo, G., Ruberto, F., Savelloni, G., Siccardi, G., Siena, A., Sterpetti, S., Valeri, S., Vera, M., Volpicelli, L., Watanabe, M., Aiuti, M., Campagna, G., Del Borgo, C., Fondaco, L., Kertusha, B., Leonetti, F., Marocco, R., Masala, R., Zuccala, P., Nonnis, G., Rigoli, A., Strumia, A., and Alampi, D.
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lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,multimorbidity ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Pneumonia, Viral ,pandemics ,Logistic regression ,metabolic diseases ,law.invention ,coronavirus infections ,male ,law ,Diabetes mellitus ,Internal medicine ,middle aged ,medicine ,80 and over ,copd ,covid-19 ,diabetes ,hypertension ,sars-cov-2 ,aged ,cardiovascular diseases ,diabetes mellitus ,female ,follow-up studies ,humans ,pneumonia ,viral ,prognosis ,retrospective studies ,risk factors ,betacoronavirus ,COPD ,Original Investigation ,Aged, 80 and over ,Mechanical ventilation ,business.industry ,SARS-CoV-2 ,Confounding ,Diabetes ,Retrospective cohort study ,Odds ratio ,medicine.disease ,Intensive care unit ,lcsh:RC666-701 ,Hypertension ,Cardiology and Cardiovascular Medicine ,business ,Covid-19 - Abstract
Background Cardiometabolic disorders may worsen Covid-19 outcomes. We investigated features and Covid-19 outcomes for patients with or without diabetes, and with or without cardiometabolic multimorbidity. Methods We collected and compared data retrospectively from patients hospitalized for Covid-19 with and without diabetes, and with and without cardiometabolic multimorbidity (defined as ≥ two of three risk factors of diabetes, hypertension or dyslipidaemia). Multivariate logistic regression was used to assess the risk of the primary composite outcome (any of mechanical ventilation, admission to an intensive care unit [ICU] or death) in patients with diabetes and in those with cardiometabolic multimorbidity, adjusting for confounders. Results Of 354 patients enrolled, those with diabetes (n = 81), compared with those without diabetes (n = 273), had characteristics associated with the primary composite outcome that included older age, higher prevalence of hypertension and chronic obstructive pulmonary disease (COPD), higher levels of inflammatory markers and a lower PaO2/FIO2 ratio. The risk of the primary composite outcome in the 277 patients who completed the study as of May 15th, 2020, was higher in those with diabetes (Adjusted Odds Ratio (adjOR) 2.04, 95%CI 1.12–3.73, p = 0.020), hypertension (adjOR 2.31, 95%CI: 1.37–3.92, p = 0.002) and COPD (adjOR 2.67, 95%CI 1.23–5.80, p = 0.013). Patients with cardiometabolic multimorbidity were at higher risk compared to patients with no cardiometabolic conditions (adjOR 3.19 95%CI 1.61–6.34, p = 0.001). The risk for patients with a single cardiometabolic risk factor did not differ with that for patients with no cardiometabolic risk factors (adjOR 1.66, 0.90–3.06, adjp = 0.10). Conclusions Patients with diabetes hospitalized for Covid-19 present with high-risk features. They are at increased risk of adverse outcomes, likely because diabetes clusters with other cardiometabolic conditions.
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- 2020
8. Risk of microvascular complications over 30 years in latent autoimmune diabetes of adults compared with type 2 diabetes
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Maddaloni, E, Coleman, R, Agbaje, O, Buzzetti, R, and Holman, R
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- 2020
9. Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes the TRIGR randomized clinical trial
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Knip M., Akerblom H. K., Altaji E., Becker D., Bruining J., Castano L., Danne T., De Beaufort C., Dosch H. -M., Dupre J., Fraser W. D., Howard N., Ilonen J., Konrad D., Kordonouri O., Krischer J. P., Lawson M. L., Ludvigsson J., Madacsy L., Mahon J. L., Ormisson A., Palmer J. P., Pozzilli P., Savilahti E., Serrano-Rios M., Songini M., Taback S., Vaarala O., White N. H., Virtanen S. M., Wasikowa R., Mandrup-Poulsen T., Arjas E., Lernmark A., Laara E., Schmidt B., Hyytinen M., Koski K., Koski M., Merentie K., Pajakkala E., Reunanen A., Salonen M., Terhonen T., Virkkunen S., Cuthbertson D., Gainer B., Hadley D., Malloy J., Nallamshetty L., Shanker L., Bradley B., Lough G., Fraser W., Sermer M., Taback S. P., Franciscus M., Nucci A., Palmer J., Alahuhta K., Barlund S., Korhonen T., Kovanen L., Lehtonen E., Niinisto S., Pekkala M., Sorkio S., Toivanen L., Vahatalo L., Uusitalo U., Ohman T., Bongiorno R., Catteau J., Fraser G., Lloyd M., Crock P., Giles M., Siech K., See D. W., Brown C., Craig M., Johnston A., Bere L. J., Clarson C. L., Jenner M., McManus R., Renato N., Lovell M., Higo D., Kent N., Kwan J., Marshall C., Metzger D., Chanoine J. -P., Stewart L., Thompson D., Edwards A., Lange I., Mercer J., Pacaud D., Josephine H., Schwarz W., Stephure D. K., Boer J., Chatur T., Chick C., Couch B., Demianczuk N., Girgis R., Marks S., Ryan E., Thompson M., Dean H. J., Grant L., Hamelin K., LaForte J., Murphy L., Catte D., Schneider C., Sellers E. A. C., Woo V., Boland A., Clark H. D., Cooper T., Gruslin A., Karovitch A., Keely E., Malcolm J. C., Sauro V., Tawagi G. F., Andrighetti S., Arnold G., Barrett J., Blumer I., Daneman D., Donat D., Ehrlich R., Feig D., Gottesman I., Gysler M., Karkanis S., Kenshole A., Knight B., Lackie E., Lewis V., Martin M. J., Maxwell C., Oliver G., Panchum P., Shilletto N., Simone A., Skidmore M., Turrini T., Wong S., Allen C., Belanger L., Bouchard I., Ferland S., Frenette L., Garrido-Russo M., Leblanc M., Imbeault J., Morin V., Olivier G., Weisnagell J., Costain G., Dornan J., Heath K., MacSween M. -C., McGibbon A., Ramsay C., Sanderson F., Sanderson S., Benabdesselam L., Gonthier M., Huot C., Thibeault M., Laforte D., Legault L., Perron P., Armson A., Canning P., Cummings E. A., Ivanko V., McLeod L., Mokashi A., Scott K., Bridger T., Crane J., Crummell C., Curtis J. C., Dawson C., Joyce C., Newhook L. A., Newman S., Druken E., Begum-Hasan J., Breen A., Houlden R., Woods M., Carrson G., Kelly S., Martel M. J., Penner M., Sankaran K., Hardy-Brown K., King N., White R. A., Park M., Popkin J., Robson L., Coles K., Al Taji E., Cerna M., Cerny M., Francova H., Hainerova I., Kothankova H., Koukalova R., Krakorova V., Mendlova P., Sitova R., Stechova K., Vavrinec J., Vosahlo J., Zlatohlavkova B., Brazdova L., Faksova P., Gregorova D., Kantor L., Malkova K., Venhacova J., Venhacova P., Cipra A., Skvor J., Budejovice C., Tomsikova Z., Botkova-Krauseova H., Mockova A., Paterova P., Gogelova P., Kandrnalova J., Einberg U., Jakovlev U., Posiadlo S., Rannaste E., Raukas R., Riikjarv M. -A., Valla K., Astover V., Kirss A., Retpap J., Taht E., Tillmann V., Vahtra S., Heikkila M., Hirvasniemi M., Luopajarvi K., Johansson S., Kleemola P., Laukkanen E., Parkkola A., Pigg H. -M., Puttonen H., Renlund M., Salonen K., Suomalainen H., Tenkula T., Teramo K., Jarvenpaa A. -L., Hamalainen A. -M., Jussila R., Kiiveri S., Haavisto H., Holopainen S., Kupiainen H., Leeve T., Lumme K., Nironen T., Tenhola S., Tiilikainen T., Keinonen H., Lautala P., Salonen P., Vesanto M., Aspholm A. S., Asunta P., Ikavalko H., Jason E., Jaminki S., Kekki P., Koskinen M., Lehtimaki S., Lahde J., Makela M., Peltoniemi S., Poutiainen L., Ranta K., Salonsaari T., Sarviharju-Tujula S. -L., Selvenius J., Siljander H., Haanpaa P. -L., Holm C., Juutilainen A., Jarvelainen V., Kangaskolkka-Keskilohko A. -M., Laino E., Marjamaki L., Suominen E., Ylitalo S., Hokkanen M., Lounamaa R., Matikainen M., Nuuja A., Paalanen I., Puupponen A. R., Salo-Edwards H., Alanne S., Kultti T., Linjama H., Muhonen K., Vaaraniemi M., Talvitie T., Backman M., Hanhijarvi R., Koivula P., Lindstrom K., Martikainen A., Nurmi P., Bjork A., Huopio H., Komulainen J., Lehtomaki S., Muikku E., Pesola J., Sankilampi U., Arkkola T., Hekkala A., Jurvakainen S., Koivikko M. -L., Kahonen M., Leinonen E., Mykkanen T., Pohjola H., Riikonen K., Niittyvuopio A., Stenius A., Tapanainen P., Veijola R., Alar A., Jovio S., Korpela P., Makinen E., Hietanen L., Kivisto J., Kaar M. -L., Lehtimaki P., Mustila T., Popov E., Saatela S., Taittonen L., Ahtiainen K., Laaksonen N., Luoto M., Viitala J., Virransalo R., Nykanen P., Paajanen S., Parkkinen S., Pyrhonen H., Sarkka T., Aschemeier B., Bektas S., Biester T., Datz N., Deiss D., Fath M., Lupke K., Muller B., Nestoris C., Rothes S., Sadeghian E., Semler K., Arato A., Krikovszky D., Nobilis A., Szenasi J., Benevento D., Anguissola G. B., Biagioni M., Bizzarri C., Cherubini V., Ferrito L., Giordano C., Giorgetti C., Khazrai Y. M., Kyanvash S., Maddaloni E., Napoli A., Piergiovanni F., Pitocco D., Suraci T., Tabacco G., Valente L., Visalli N., Carboni M. B., Cavallo R., Cau V., Isola C., Ledda A., Loddo M., Mannu C., Pettinau M., Pisano S., Porceddu M., Putzu C., Rita A., Peters D., Schierloh U., Bisschoff M., Blonk L., Lappenschaar T., Manai B., Seesink M., Sperling-Conrad M., Verhagen M., Zoethout J. A., Basiak A., Chalas M., Chesiak M., Gramza A., Iwankiewicz J., Sieradzan E., Wikiera B., Ciechanowska M., Dziatkowiak H., Futona B., Gorska A., Glowacka-Wony M., Kaim I., Klich B., Starzyk J., Wolanin M., Tokarska L., Chucherco D., Deja G., Firek-Pedras M., Jarosz-Chobot P., Kalina M., Kutrowska-Adamusiak K., Minkina-Pedras M., Muchaka-Bianga M., Bodalski J., Mlynarski W., Szadkowska A., Cieslak A., Cypryk K., Dziatosz K., Jastzebowska J., Krysiak A., Szymanska U., Wilcznski J., Zawodniak-Szalapska M., Aguay A., Bilbao J. R., Chueca M., Cortazar A., Echarte G., Frutos T. G., Jimenez P., Martul P., Moreno A., Oyarzabal M., Rica I., Salgado Y., Martinez-Larrad M. T., Hawkins F. G., Hernandez R., Herranz L., Pallardo L. F., Deibarra L. S., Fernandez B. H., Luis J. L., Ortiz-Quintana L., Recarte P. P., Arnau D. R., Aronsson L., Boden S., Fredriksson J., Isacsson E., Johansson I., Karlsson E., Lock C., Sandstrom A. -M., Konefal M. S., Andreasson C., Dahlstrom U., Hanas R., Lundqvist K., Windell L., Jansson I., Karlsson A. -K., Lindbladh B., Odenman I., Pettersson C., Sundberg F., Sundqvist M., Aronsson S., Bellman I., Bengtsson A. -B., Lyden G. -B., Nilsson N. -O., Soderblom M., Unt C., Augustsson M., Bengtsson M., Fors H., Helmrich A., Johansson T. O., Andersson A. -C., Boiard-Stomlid A., Hellgren G., Kallsholm H., Lindqvist J., Nilsson M., Nordwall M., Stromstedt C., Ahsberg C., Lindh A., Lindhe C., Samuelsson C., Wiik A., Edenwall H., Ljumgcrantz M., Persson I. -B., Strigard E., Svensson B. -L., Aman J., Breivik G. -E., Detlofsson I. -L., Kroon M., Sarnblad S., Johansson C., Ilvered R., Lundberg A., Akesson K., Beccarelli A., Gadient M., Rappold-Amrein C., Schoenle E., Daftary A., Damagro-Elias M. E., Gilmour C., Klein M. B., Lain C., Salerno D., Smith M. E., Vats K., Pfaff D. J., Malone P., Mansfield P., Munns M., Nickel K., Pompilio K., Siemion W., Taculad R., Van Horn K., Zdanadewic M., Chambliss C., Jones J., Sadler M., Tanner-Blasiar M., Bell C., Camper N., Devaskar S., Devaskar U., Horowitz H., Rogers L., Shannahan R., Silk K., Bermudez Z., Colon R., Frazer T., Martinez-Nieves B., Torres J., Vega J., Chan M., Cook S., Goland R., Greenberg E., Jules N., Montes J., Nelson M., Parra-Valencia Z., Schachner H., Softness B., Kiviniemi M., Suomenin R., Alexander A., Hyrckowian E., Nichol L., Trucco M., Karjalainen E., Louhio T., Sarnesto A., Valtonen E., Davydova B., Helander S., Hamalainen J., Harkonen T., Joutsjoki L., Kararic M., Latva-Koivisto M., Lonn E., Nurmi T., Ollila I., Rinkinen J., Ronkainen M., Tukiainen H., Cederlof A., Kiikeri M., Tsupari S., Cheng R., Bryant K., Chan Y., Maezawa Y., Paltser G., Rasavi R., Tsui H., Winer S., Wu P., Yantha J., Pediatrics, Knip M., Akerblom H.K., Altaji E., Becker D., Bruining J., Castano L., Danne T., De Beaufort C., Dosch H.-M., Dupre J., Fraser W.D., Howard N., Ilonen J., Konrad D., Kordonouri O., Krischer J.P., Lawson M.L., Ludvigsson J., Madacsy L., Mahon J.L., Ormisson A., Palmer J.P., Pozzilli P., Savilahti E., Serrano-Rios M., Songini M., Taback S., Vaarala O., White N.H., Virtanen S.M., Wasikowa R., Mandrup-Poulsen T., Arjas E., Lernmark A., Laara E., Schmidt B., Hyytinen M., Koski K., Koski M., Merentie K., Pajakkala E., Reunanen A., Salonen M., Terhonen T., Virkkunen S., Cuthbertson D., Gainer B., Hadley D., Malloy J., Nallamshetty L., Shanker L., Bradley B., Lough G., Fraser W., Sermer M., Taback S.P., Franciscus M., Nucci A., Palmer J., Alahuhta K., Barlund S., Korhonen T., Kovanen L., Lehtonen E., Niinisto S., Pekkala M., Sorkio S., Toivanen L., Vahatalo L., Uusitalo U., Ohman T., Bongiorno R., Catteau J., Fraser G., Lloyd M., Crock P., Giles M., Siech K., See D.W., Brown C., Craig M., Johnston A., Bere L.J., Clarson C.L., Jenner M., McManus R., Renato N., Lovell M., Higo D., Kent N., Kwan J., Marshall C., Metzger D., Chanoine J.-P., Stewart L., Thompson D., Edwards A., Lange I., Mercer J., Pacaud D., Josephine H., Schwarz W., Stephure D.K., Boer J., Chatur T., Chick C., Couch B., Demianczuk N., Girgis R., Marks S., Ryan E., Thompson M., Dean H.J., Grant L., Hamelin K., LaForte J., Murphy L., Catte D., Schneider C., Sellers E.A.C., Woo V., Boland A., Clark H.D., Cooper T., Gruslin A., Karovitch A., Keely E., Malcolm J.C., Sauro V., Tawagi G.F., Andrighetti S., Arnold G., Barrett J., Blumer I., Daneman D., Donat D., Ehrlich R., Feig D., Gottesman I., Gysler M., Karkanis S., Kenshole A., Knight B., Lackie E., Lewis V., Martin M.J., Maxwell C., Oliver G., Panchum P., Shilletto N., Simone A., Skidmore M., Turrini T., Wong S., Allen C., Belanger L., Bouchard I., Ferland S., Frenette L., Garrido-Russo M., Leblanc M., Imbeault J., Morin V., Olivier G., Weisnagell J., Costain G., Dornan J., Heath K., MacSween M.-C., McGibbon A., Ramsay C., Sanderson F., Sanderson S., Benabdesselam L., Gonthier M., Huot C., Thibeault M., Laforte D., Legault L., Perron P., Armson A., Canning P., Cummings E.A., Ivanko V., McLeod L., Mokashi A., Scott K., Bridger T., Crane J., Crummell C., Curtis J.C., Dawson C., Joyce C., Newhook L.A., Newman S., Druken E., Begum-Hasan J., Breen A., Houlden R., Woods M., Carrson G., Kelly S., Martel M.J., Penner M., Sankaran K., Hardy-Brown K., King N., White R.A., Park M., Popkin J., Robson L., Coles K., Al Taji E., Cerna M., Cerny M., Francova H., Hainerova I., Kothankova H., Koukalova R., Krakorova V., Mendlova P., Sitova R., Stechova K., Vavrinec J., Vosahlo J., Zlatohlavkova B., Brazdova L., Faksova P., Gregorova D., Kantor L., Malkova K., Venhacova J., Venhacova P., Cipra A., Skvor J., Budejovice C., Tomsikova Z., Botkova-Krauseova H., Mockova A., Paterova P., Gogelova P., Kandrnalova J., Einberg U., Jakovlev U., Posiadlo S., Rannaste E., Raukas R., Riikjarv M.-A., Valla K., Astover V., Kirss A., Retpap J., Taht E., Tillmann V., Vahtra S., Heikkila M., Hirvasniemi M., Luopajarvi K., Johansson S., Kleemola P., Laukkanen E., Parkkola A., Pigg H.-M., Puttonen H., Renlund M., Salonen K., Suomalainen H., Tenkula T., Teramo K., Jarvenpaa A.-L., Hamalainen A.-M., Jussila R., Kiiveri S., Haavisto H., Holopainen S., Kupiainen H., Leeve T., Lumme K., Nironen T., Tenhola S., Tiilikainen T., Keinonen H., Lautala P., Salonen P., Vesanto M., Aspholm A.S., Asunta P., Ikavalko H., Jason E., Jaminki S., Kekki P., Koskinen M., Lehtimaki S., Lahde J., Makela M., Peltoniemi S., Poutiainen L., Ranta K., Salonsaari T., Sarviharju-Tujula S.-L., Selvenius J., Siljander H., Haanpaa P.-L., Holm C., Juutilainen A., Jarvelainen V., Kangaskolkka-Keskilohko A.-M., Laino E., Marjamaki L., Suominen E., Ylitalo S., Hokkanen M., Lounamaa R., Matikainen M., Nuuja A., Paalanen I., Puupponen A.R., Salo-Edwards H., Alanne S., Kultti T., Linjama H., Muhonen K., Vaaraniemi M., Talvitie T., Backman M., Hanhijarvi R., Koivula P., Lindstrom K., Martikainen A., Nurmi P., Bjork A., Huopio H., Komulainen J., Lehtomaki S., Muikku E., Pesola J., Sankilampi U., Arkkola T., Hekkala A., Jurvakainen S., Koivikko M.-L., Kahonen M., Leinonen E., Mykkanen T., Pohjola H., Riikonen K., Niittyvuopio A., Stenius A., Tapanainen P., Veijola R., Alar A., Jovio S., Korpela P., Makinen E., Hietanen L., Kivisto J., Kaar M.-L., Lehtimaki P., Mustila T., Popov E., Saatela S., Taittonen L., Ahtiainen K., Laaksonen N., Luoto M., Viitala J., Virransalo R., Nykanen P., Paajanen S., Parkkinen S., Pyrhonen H., Sarkka T., Aschemeier B., Bektas S., Biester T., Datz N., Deiss D., Fath M., Lupke K., Muller B., Nestoris C., Rothes S., Sadeghian E., Semler K., Arato A., Krikovszky D., Nobilis A., Szenasi J., Benevento D., Anguissola G.B., Biagioni M., Bizzarri C., Cherubini V., Ferrito L., Giordano C., Giorgetti C., Khazrai Y.M., Kyanvash S., Maddaloni E., Napoli A., Piergiovanni F., Pitocco D., Suraci T., Tabacco G., Valente L., Visalli N., Carboni M.B., Cavallo R., Cau V., Isola C., Ledda A., Loddo M., Mannu C., Pettinau M., Pisano S., Porceddu M., Putzu C., Rita A., Peters D., Schierloh U., Bisschoff M., Blonk L., Lappenschaar T., Manai B., Seesink M., Sperling-Conrad M., Verhagen M., Zoethout J.A., Basiak A., Chalas M., Chesiak M., Gramza A., Iwankiewicz J., Sieradzan E., Wikiera B., Ciechanowska M., Dziatkowiak H., Futona B., Gorska A., Glowacka-Wony M., Kaim I., Klich B., Starzyk J., Wolanin M., Tokarska L., Chucherco D., Deja G., Firek-Pedras M., Jarosz-Chobot P., Kalina M., Kutrowska-Adamusiak K., Minkina-Pedras M., Muchaka-Bianga M., Bodalski J., Mlynarski W., Szadkowska A., Cieslak A., Cypryk K., Dziatosz K., Jastzebowska J., Krysiak A., Szymanska U., Wilcznski J., Zawodniak-Szalapska M., Aguay A., Bilbao J.R., Chueca M., Cortazar A., Echarte G., Frutos T.G., Jimenez P., Martul P., Moreno A., Oyarzabal M., Rica I., Salgado Y., Martinez-Larrad M.T., Hawkins F.G., Hernandez R., Herranz L., Pallardo L.F., Deibarra L.S., Fernandez B.H., Luis J.L., Ortiz-Quintana L., Recarte P.P., Arnau D.R., Aronsson L., Boden S., Fredriksson J., Isacsson E., Johansson I., Karlsson E., Lock C., Sandstrom A.-M., Konefal M.S., Andreasson C., Dahlstrom U., Hanas R., Lundqvist K., Windell L., Jansson I., Karlsson A.-K., Lindbladh B., Odenman I., Pettersson C., Sundberg F., Sundqvist M., Aronsson S., Bellman I., Bengtsson A.-B., Lyden G.-B., Nilsson N.-O., Soderblom M., Unt C., Augustsson M., Bengtsson M., Fors H., Helmrich A., Johansson T.O., Andersson A.-C., Boiard-Stomlid A., Hellgren G., Kallsholm H., Lindqvist J., Nilsson M., Nordwall M., Stromstedt C., Ahsberg C., Lindh A., Lindhe C., Samuelsson C., Wiik A., Edenwall H., Ljumgcrantz M., Persson I.-B., Strigard E., Svensson B.-L., Aman J., Breivik G.-E., Detlofsson I.-L., Kroon M., Sarnblad S., Johansson C., Ilvered R., Lundberg A., Akesson K., Beccarelli A., Gadient M., Rappold-Amrein C., Schoenle E., Daftary A., Damagro-Elias M.E., Gilmour C., Klein M.B., Lain C., Salerno D., Smith M.E., Vats K., Pfaff D.J., Malone P., Mansfield P., Munns M., Nickel K., Pompilio K., Siemion W., Taculad R., Van Horn K., Zdanadewic M., Chambliss C., Jones J., Sadler M., Tanner-Blasiar M., Bell C., Camper N., Devaskar S., Devaskar U., Horowitz H., Rogers L., Shannahan R., Silk K., Bermudez Z., Colon R., Frazer T., Martinez-Nieves B., Torres J., Vega J., Chan M., Cook S., Goland R., Greenberg E., Jules N., Montes J., Nelson M., Parra-Valencia Z., Schachner H., Softness B., Kiviniemi M., Suomenin R., Alexander A., Hyrckowian E., Nichol L., Trucco M., Karjalainen E., Louhio T., Sarnesto A., Valtonen E., Davydova B., Helander S., Hamalainen J., Harkonen T., Joutsjoki L., Kararic M., Latva-Koivisto M., Lonn E., Nurmi T., Ollila I., Rinkinen J., Ronkainen M., Tukiainen H., Cederlof A., Kiikeri M., Tsupari S., Cheng R., Bryant K., Chan Y., Maezawa Y., Paltser G., Rasavi R., Tsui H., Winer S., Wu P., Yantha J., University of Zurich, and Knip, Mikael
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Male ,Risk ,medicine.medical_specialty ,Casein ,Breastfeeding ,030209 endocrinology & metabolism ,610 Medicine & health ,2700 General Medicine ,Endocrinology and Diabetes ,Disease-Free Survival ,law.invention ,Follow-Up Studie ,Nutrition Policy ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,SDG 3 - Good Health and Well-being ,law ,Internal medicine ,Diabetes mellitus ,medicine ,Humans ,Cumulative incidence ,030212 general & internal medicine ,Child ,Infant Nutritional Physiological Phenomena ,Original Investigation ,2. Zero hunger ,Type 1 diabetes ,business.industry ,Hazard ratio ,Absolute risk reduction ,Infant, Newborn ,Caseins ,General Medicine ,ta3121 ,medicine.disease ,Infant Formula ,3. Good health ,Diabetes Mellitus, Type 1 ,Infant formula ,10036 Medical Clinic ,Endokrinologi och diabetes ,Female ,business ,Human ,Follow-Up Studies - Abstract
IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. INTERVENTIONS The participants received either a casein hydrolysate or a conventional adapted cows milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. MAIN OUTCOMES AND MEASURES Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). RESULTS Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8%[95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes. Funding Agencies|Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD); National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health [HD040364, HD042444, HD051997]; Canadian Institutes of Health Research; Commission of the European Communities [QLK1-2002-00372]; European Foundation for the Study of Diabates/JDRF/Novo Nordisk; Academy of Finland (Centre of Excellence in Molecular Systems Immunology and Physiology Research) [250114]; Dutch Diabetes Research Foundation; Finnish Diabetes Research Foundation; JDRF
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- 2018
10. Prevention of atherothrombotic events in patients with diabetes mellitus: from antithrombotic therapies to new-generation glucose-lowering drugs
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Patti, G., Cavallari, I., Andreotti, F., Calabrò, P., Cirillo, P., Denas, G., Galli, M., Golia, E., Maddaloni, E., Marcucci, R., Parato, V. M., Pengo, V., Prisco, D., Ricottini, E., Renda, G., Santilli, F., Simeone, P., De Caterina, R., on behalf of the Working Group on Thrombosis of the Italian Society of Cardiology, Patti, Giuseppe, Cavallari, Ilaria, Andreotti, Felicita, Calabrò, Paolo, Cirillo, Plinio, Denas, Gentian, Galli, Mattia, Golia, Enrica, Maddaloni, Ernesto, Marcucci, Rossella, Parato, Vito Maurizio, Pengo, Vittorio, Prisco, Domenico, Ricottini, Elisabetta, Renda, Giulia, Santilli, Francesca, Simeone, Paola, and De Caterina, Raffaele
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0301 basic medicine ,diabetes ,thrombosis ,cardiovascular events ,antithrombotic drugs ,medicine.medical_specialty ,Disease ,030204 cardiovascular system & hematology ,blood coagulation ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Fibrinolytic Agents ,Risk Factors ,Diabetes mellitus ,Antithrombotic ,Diabetes Mellitus ,Secondary Prevention ,medicine ,Humans ,Hypoglycemic Agents ,atherothrombotic events, diabetes mellitus, prevention, glucose-lowering drugs ,Risk factor ,Intensive care medicine ,Diabetes, Cardiovascular Disease, Thrombosis ,Preventive medicine ,business.industry ,Consensus Statement ,Thrombosis ,Type 2 diabetes ,Atrial fibrillation ,Guideline ,medicine.disease ,Type 1 diabetes ,030104 developmental biology ,Cardiovascular Diseases ,Practice Guidelines as Topic ,Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Drug therapy ,Cardiology and Cardiovascular Medicine ,business - Abstract
Diabetes mellitus is an important risk factor for a first cardiovascular event and for worse outcomes after a cardiovascular event has occurred. This situation might be caused, at least in part, by the prothrombotic status observed in patients with diabetes. Therefore, contemporary antithrombotic strategies, including more potent agents or drug combinations, might provide greater clinical benefit in patients with diabetes than in those without diabetes. In this Consensus Statement, our Working Group explores the mechanisms of platelet and coagulation activity, the current debate on antiplatelet therapy in primary cardiovascular disease prevention, and the benefit of various antithrombotic approaches in secondary prevention of cardiovascular disease in patients with diabetes. While acknowledging that current data are often derived from underpowered, observational studies or subgroup analyses of larger trials, we propose antithrombotic strategies for patients with diabetes in various cardiovascular settings (primary prevention, stable coronary artery disease, acute coronary syndromes, ischaemic stroke and transient ischaemic attack, peripheral artery disease, atrial fibrillation, and venous thromboembolism). Finally, we summarize the improvements in cardiovascular outcomes observed with the latest glucose-lowering drugs, and on the basis of the available evidence, we expand and integrate current guideline recommendations on antithrombotic strategies in patients with diabetes for both primary and secondary prevention of cardiovascular disease., Patients with diabetes mellitus have a prothrombotic status that increases the risk of cardiovascular events and worsens prognosis after these events. In this Consensus Statement, the Working Group on Thrombosis of the Italian Society of Cardiology proposes antithrombotic strategies for patients with diabetes in various cardiovascular settings.
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- 2019
11. Erratum to: Serum chitotriosidase in postmenopausal women with severe osteoporosis
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Musumeci, M., Palermo, A., D’Onofrio, L., Vadalà, G., Greto, V., Di Stasio, E., Maddaloni, E., Di Rosa, M., Tibullo, D., Angeletti, S., Napoli, N., Denaro, V., and Manfrini, S.
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- 2016
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12. Wrist circumference is a biomarker of adipose tissue dysfunction and cardiovascular risk in children with obesity
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Luordi, C., primary, Maddaloni, E., additional, Bizzarri, C., additional, Pedicelli, S., additional, Zampetti, S., additional, D’Onofrio, L., additional, Moretti, C., additional, Cappa, M., additional, and Buzzetti, R., additional
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- 2019
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13. Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial
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Nucci, A. M., Virtanen, S. M., Sorkio, S., Barlund, S., Cuthbertson, D., Uusitalo, U., Lawson, M. L., Salonen, M., Berseth, C. L., Ormisson, A., Lehtonen, E., Savilahti, E., Becker, D. J., Dupre, J., Krischer, J. P., Knip, M., Akerblom, H. K., Mandrup-Poulsen, T., Arjas, E., Laara, E., Lernmark, A., Schmidt, B., Hyytinen, M., Koski, K., Koski, M., Pajakkala, E., Shanker, L., Bradley, B., Dosch, H. -M., Fraser, W., Lawson, M., Mahon, J. L., Sermer, M., Taback, S. P., Becker, D., Franciscus, M., Nucci, A., Palmer, J., Pekkala, M., Catteau, J., Howard, N., Crock, P., Craig, M., Clarson, C. L., Bere, L., Thompson, D., Metzger, D., Kwan, J., Stephure, D. K., Pacaud, D., Ho, J., Schwarz, W., Girgis, R., Thompson, M., Catte, D., Daneman, D., Martin, M. -J., Morin, V., Frenette, L., Ferland, S., Sanderson, S., Heath, K., Huot, C., Gonthier, M., Thibeault, M., Legault, L., Laforte, D., Cummings, E. A., Scott, K., Bridger, T., Crummell, C., Newman, S., Houlden, R., Breen, A., Carson, G., Kelly, S., Sankaran, K., Penner, M., White, R. A., Hardy Brown, K., King, N., Popkin, J., Robson, L., Coles, K., Al Taji, E., Aldhoon, I., Mendlova, P., Vavrinec, J., Vosahlo, J., Brazdova, L., Venhacova, J., Venhacova, P., Cipra, A., Tomsikova, Z., Paterova, P., Gogelova, P., Einberg, U., Riikjarv, M. -A., Tillmann, V., Hirvasniemi, M., Kleemola, P., Parkkola, A., Suomalainen, H., Jarvenpaa, A. -L., Hamalainen, A. -M., Haavisto, H., Tenhola, S., Lautala, P., Salonen, P., Aspholm, S., Siljander, H., Holm, C., Ylitalo, S., Lounamaa, R., Nuuja, A., Talvitie, T., Lindstrom, K., Huopio, H., Pesola, J., Veijola, R., Tapanainen, P., Alar, A., Korpela, P., Kaar, M. -L., Mustila, T., Virransalo, R., Nykanen, P., Aschemeier, B., Danne, T., Kordonouri, O., Krikovszky, D., Madacsy, L., Khazrai, Y. M., Maddaloni, E., Pozzilli, P., Mannu, C., Songini, M., de Beaufort, C., Schierloh, U., Bruining, J., Basiak, A., Wasikowa, R., Ciechanowska, M., Deja, G., Jarosz-Chobot, P., Szadkowska, A., Cypryk, K., Zawodniak-Szalapska, M., Castano, L., Gonzalez Frutos, T., Oyarzabal, M., Serrano-Rios, M., Martinez-Larrad, M. T., Hawkins, F. G., Rodriguez Arnau, D., Ludvigsson, J., Smolinska Konefal, M., Hanas, R., Lindblad, B., Nilsson, N. -O., Fors, H., Nordwall, M., Lindh, A., Edenwall, H., Aman, J., Johansson, C., Gadient, M., Schoenle, E., Daftary, A., Klein, M. B., Gilmour, C., Malone, P., Tanner-Blasiar, M., White, N., Devaskar, U., Horowitz, H., Rogers, L., Colon, R., Frazer, T., Torres, J., Goland, R., Greenberg, E., Nelson, M., Schachner, H., Softness, B., Ilonen, J., Trucco, M., Nichol, L., Harkonen, T., Vaarala, O., and Luopajarvi, K.
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Canada ,endocrine system diseases ,infant feeding ,breastfeeding ,type 1 diabetes ,breastfeeding duration ,complementary feeding ,infant formula ,Infant ,Article ,United States ,Diet ,Nutrition Policy ,Europe ,Diabetes Mellitus, Type 1 ,Milk ,Nutrition Assessment ,Double-Blind Method ,Surveys and Questionnaires ,Animals ,Humans ,Infant Food ,Prospective Studies ,Infant Nutritional Physiological Phenomena - Abstract
Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.
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- 2017
14. Il ruolo del biostatistico nella preparazione conduzione e monitoraggio delle sperimentazioni cliniche
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Maddaloni, E, Strollo, R, and Pozzilli, P
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BIOSTATISTICA ,STATISTICA MEDICA ,SPERIMENTAZIONE CLINICA - Published
- 2017
15. Differences between ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifications performance in identifying cytological high-risk thyroid nodules
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Lauria Pantano, A, primary, Maddaloni, E, additional, Briganti, S I, additional, Beretta Anguissola, G, additional, Perrella, E, additional, Taffon, C, additional, Palermo, A, additional, Pozzilli, P, additional, Manfrini, S, additional, and Crescenzi, A, additional
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- 2018
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16. Tipo 1 e LADA in crescita: prevenzione e assistenza ottimale
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Maddaloni, E and Pozzilli, P
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Prevenzione ,Diabete tipo 1 ,LADA ,Diabete autoimmune - Published
- 2016
17. Differences between ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifications performance in identifying cytological high-risk thyroid nodules.
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Pantano, A. Lauria, Maddaloni, E., Briganti, S. I., Anguisso, G. Beretta, Perrella, E., Taffon, C., Palermo, A., Pozzilli, P., Manfrini, S., and Crescenzi, A.
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CYTOLOGY , *DECISION making in clinical medicine ,THYROID disease diagnosis - Abstract
Objective: Thyroid ultrasound is crucial for clinical decision in the management of thyroid nodules. In this study, we aimed to estimate and compare the performance of ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifcations in discriminating nodules with high-risk cytology. Design: Cross-sectional study. Methods: 1077 thyroid nodules undergoing fne-needle aspiration were classifed according to ATA, AACE/ACE/AME and ACR TI-RADS ultrasound classifcations by an automated algorithm. Odds ratios (ORs) and receiver operating characteristic (ROC) curves for high-risk cytology categories (TIR3b, TIR4 and TIR5) were calculated for the different US categories and compared. Results: Cytological categories of risk increased together with all US classifcations' sonographic patterns (P < 0.001). The diagnostic performance (C-index) of ACR TI-RADS and AACE/ACE/AME signifcantly improved when adding clinical data as gender and age in the regression model (P < 0.001). A signifcant difference in the fnal model C-index between the three US classifcation systems was found (P < 0.029), with the ACR TI-RADS showing the highest nominal C-index value, signifcantly superior to ATA (P = 0.008), but similar to AACE/ACE/AME (P = 0.287). ATA classifcation was not able to classify 54 nodules, which showed a signifcant 7 times higher risk of high-risk cytology than the 'very low suspicion' nodules (OR: 7.20 (95% confdence interval: 2.44-21.24), P < 0.001). Conclusions: The ACR TI-RADS classifcation system has the highest area under the ROC curve for the identifcation of cytological high-risk nodules. ATA classifcation leaves 'unclassifed' nodules at relatively high risk of malignancy. [ABSTRACT FROM AUTHOR]
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- 2018
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18. Effect of calcitriol on bone turnover and osteocalcin in recent-onset type 1 diabetes
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Napoli N, Strollo R, Pitocco, D, Bizzarri, C, Maddaloni, E, Maggi, D, Manfrini, S, Schwartz, A, Pozzilli, P, Collaborators, IMDIAB Group, Anguissola, Gb, Astorri, E, Barchetta, Ilaria, Benevento, D, Beretta Anguissola, G, Buzzetti, Raffaella, Capizzi, M, Cappa, M, Cassone Faldetta, Mr, Cavallo, Maria Gisella, Cipolloni, L, Cipponeri, E, Crinò, A, Di Stasio, E, Fioriti, E, Ghirlanda, G, Guglielmi, C, Lauria, A, Matteoli, Mc, Maurizi, Ar, Moretti, C, Napoli, N, Palermo, A, Portuesi, R, Spera, S, Strollo, R, Tuccinardi, D, and Valente, L.
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Male ,medicine.medical_treatment ,Bone remodeling ,Endocrinology ,Osteogenesis ,Insulin-Secreting Cells ,Insulin ,Age of Onset ,Vitamin D ,Child ,Multidisciplinary ,biology ,C-Peptide ,Mitochondrial medicine Energy and redox metabolism [IGMD 8] ,Vitamins ,Osteocalcin ,Medicine ,Female ,Collagen ,medicine.drug ,Research Article ,Peak bone mass ,Adult ,medicine.medical_specialty ,Calcitriol ,Adolescent ,Clinical Research Design ,Science ,Bone and Mineral Metabolism ,Bone resorption ,Autoimmune Diseases ,Rheumatology ,Internal medicine ,medicine ,Humans ,Bone Resorption ,Retrospective Studies ,Nutrition ,Glycated Hemoglobin ,Diabetic Endocrinology ,Type 1 diabetes ,Endocrine Physiology ,business.industry ,Diabetes Mellitus Type 1 ,medicine.disease ,Peptide Fragments ,Diabetes Mellitus, Type 1 ,Metabolic control analysis ,biology.protein ,Clinical Immunology ,business ,Follow-Up Studies - Abstract
Contains fulltext : 125353.pdf (Publisher’s version ) (Open Access) BACKGROUND: Vitamin D supplementation in childhood improves the achievement of peak bone mass. We investigated the effect of supplementation with calcitriol on bone turnover in recent-onset type 1 diabetes (T1D). Moreover, the association between osteocalcin and parameters of beta-cell function and metabolic control was examined. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a post-hoc analysis of a double-blind, placebo-controlled study of calcitriol supplementation to preserve beta-cell function. 27 recent-onset T1D subjects, mean age 22 years, were randomized to 0.25 microg calcitriol per day or placebo (1:1) and followed up for one year. Changes in bone formation (osteoclacin) and resorption (beta-CrossLaps) markers, and differences between placebo and calcitriol-treated group were evaluated. At baseline, osteocalcin levels were significantly lower in female than in male patients (P
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- 2012
19. Diabetes-related autoantibodies in children with acute lymphoblastic leukemia
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Bizzarri, C., Pinto, R. m., Pitocco, D., Astorri, E., Cappa, M., Hawa, M., Giannone, G., Palermo, A., Maddaloni, E., Leslie, Dr, Pozzilli, P., Altomare, M., Barchetta, Ilaria, Benevento, D., Beretta Anguissola, G., Buzzetti, Raffaella, Capizzi, M., Cappa, M. r., Cavallo, Maria Gisella, Cipolloni, L., Cipponeri, E., Costantino, F., Crino, A., Defeudis, G., Di Stasio, E., Fallucca, S., Fioriti, E., Ghirlanda, G., Guglielmi, C., Khazrai Yeganeh, M., Kyanvash, S., Lauria, A., Maggi, D., Manfrini, S., Maurizi, A. r., Moretti, C., Morviducci, L., Napoli, N., Patera, P., Portuesi, R., Schiaffini, R., Scrocca, R., Spera, S., Strollo, R., Suraci, C., Tubili, C., Tuccinardi, D., Valente, L., and Visalli, N.
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Male ,medicine.medical_specialty ,Diabetes Care Electronic Pages ,Endocrinology, Diabetes and Metabolism ,Glutamate decarboxylase ,Radioimmunoassay ,Pre B Lymphocyte ,Internal medicine ,Diabetes mellitus ,Epidemiology ,Internal Medicine ,medicine ,Diabetes Mellitus ,Humans ,Insulin ,Online Letters: Observations ,Child ,Philadelphia 1 Chromosome ,Autoantibodies ,Acute Lymphoblastic Leukemia ,Advanced and Specialized Nursing ,Type 1 diabetes ,business.industry ,Glutamate Decarboxylase ,Thyroid ,Autoantibody ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,medicine.disease ,Leukemia ,medicine.anatomical_structure ,Child, Preschool ,Immunology ,Etiology ,Female ,business - Abstract
Acute lymphoblastic leukemia (ALL) is the most common subtype of leukemia in children. Although ALL and type 1 diabetes appear to be biologically unrelated, there are common threads in both epidemiology and etiology. Rising incidence rates of both ALL (1) and type 1 diabetes (2) observed over recent decades in many Western countries seem to support common etiological factors (3). In the current study, we report on diabetes-related autoantibodies (Abs) in a group of patients with ALL. Thirty-four consecutive children (19 males and 15 females, mean age 6.2 ± 4.6 years) were referred to our institution in 2004 for newly diagnosed ALL. Patients were tested for Abs to islet and thyroid antigens. After the initial investigation and treatment, 31/34 (91%) patients (3 died in the mean time) were followedup for 6 years to evaluate the evolution of the autoimmune markers and progression toward type 1 diabetes. Glutamic acid decarboxylase (GAD) Abs by direct …
- Published
- 2012
20. Serum chitotriosidase in postmenopausal women with severe osteoporosis
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Musumeci, M., primary, Palermo, A., additional, D’Onofrio, L., additional, Vadalà, G., additional, Greto, V., additional, Di Stasio, E., additional, Maddaloni, E., additional, Di Rosa, M., additional, Tibullo, D., additional, Silvia, A., additional, Napoli, N., additional, Denaro, V., additional, and Manfrini, S., additional
- Published
- 2015
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21. In vivocorneal confocal microscopy as a novel non-invasive tool to investigate cardiac autonomic neuropathy in Type 1 diabetes
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Maddaloni, E., primary, Sabatino, F., additional, Del Toro, R., additional, Crugliano, S., additional, Grande, S., additional, Lauria Pantano, A., additional, Maurizi, A. R., additional, Palermo, A., additional, Bonini, S., additional, Pozzilli, P., additional, and Manfrini, S., additional
- Published
- 2014
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22. Comment on: “Early insulin treatment in type 2 diabetes: ORIGINal sin or valuable choice as ORIGINal treatment? An open debate on the ORIGIN study results”
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Maddaloni, E., primary and Pozzilli, P., additional
- Published
- 2014
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23. Acute reduction of lipoprotein(a) by tissue-type plasminogen activator.
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Di Lorenzo, M, primary, Salvini, P, additional, Levi Della Vida, M, additional, and Maddaloni, E, additional
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- 1993
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24. A study of blood coagulation and fibrinolytic system in spontaneous subarachnoid hemorrhage
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Nina, P., Schisano, G., Chiappetta, F., Papa, M. Luisa, Maddaloni, E., Brunori, A., Capasso, F., Corpetti, M. G., and Demurtas, F.
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- 2001
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25. Effectiveness and safety of calcium and vitamin D treatment for postmenopausal osteoporosis
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Cesareo R, Iozzino M, LUCA D'ONOFRIO, Terrinoni I, Maddaloni E, Casini A, Campagna G, Santonati A, and Palermo A
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Bone Density Conservation Agents ,Vitamins ,Calcium Compounds ,Fractures, Bone ,Treatment Outcome ,Meta-Analysis as Topic ,Dietary Supplements ,Humans ,Female ,Prospective Studies ,Vitamin D ,Osteoporosis, Postmenopausal ,Aged ,Randomized Controlled Trials as Topic - Abstract
Imbalance of bone resorption and bone formation is responsible for osteoporosis that is characterized by decreased bone mass and mineral density. The aim of this study was to evaluate the available data that could clarify the effectiveness and safety of supplementations with calcium and vitamin D, alone or in combination, to slow down bone loss in postmenopausal and elderly women. Using search key words, we performed a research both in the PubMed and Cochrane Library in order to find all meta-analysis, prospective and randomized clinical studies published from 2000 to 2014 that had investigated the effectiveness of calcium and vitamin D in the treatment of osteoporosis. At the moment it is not possible either to provide reassurance that calcium supplements given with vitamin D do not cause adverse cardiovascular events or to link them with certainty to increased cardiovascular risk. According to the data now available, vitamin D, at dosage of at least 800 IU/day, alone or in combination with antiresorptive drugs, should be administered in osteoporotic and osteopenic patients for a primary and secondary prevention. Further studies are needed and the debate remains ongoing. However, every administration needs the calculation of the absolute fracture risk of the patient. Especially considering the high cost of osteoporosis prevention, more studies are mandatory to clarify indications and contraindications.
26. Diabetes-related autoantibodies in children with acute lymphoblastic leukemia.
- Author
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Bizzarri C, Pinto RM, Pitocco D, Astorri E, Cappa M, Hawa M, Giannone G, Palermo A, Maddaloni E, Leslie DR, Pozzilli P, IMDIAB Group, Bizzarri, Carla, Pinto, Rita M, Pitocco, Dario, Astorri, Elisa, Cappa, Marco, Hawa, Mohammed, Giannone, Germana, and Palermo, Andrea
- Published
- 2012
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27. The complex combination of COVID-19 and diabetes: pleiotropic changes in glucose metabolism
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Giovanna Muscogiuri, Raffaella Buzzetti, Abdolkarim Mahrooz, Ernesto Maddaloni, Mahrooz, A., Muscogiuri, G., Buzzetti, R., and Maddaloni, E.
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Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,Inflammation ,Review ,Oxidative phosphorylation ,Carbohydrate metabolism ,Diabete ,Bioinformatics ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Immune system ,Diabetes mellitus ,Diabetes Mellitus ,medicine ,Humans ,Glycolysis ,Glucose metabolism ,SARS-CoV-2 ,business.industry ,Diabetes ,COVID-19 ,medicine.disease ,diabetes ,glucose metabolism ,long-term consequences ,Glucose ,030220 oncology & carcinogenesis ,Angiotensin-converting enzyme 2 ,Long-term consequences ,medicine.symptom ,Long-term consequence ,business ,Cytokine storm ,Human - Abstract
Purpose: Angiotensin converting enzyme 2 (ACE2) is the door for SARS-CoV-2, expressed in critical metabolic tissues. So, it is rational that the new virus causes pleiotropic alterations in glucose metabolism, resulting in the complication of pre-existing diabetes’s pathophysiology or creating new disease mechanisms. However, it seems that less attention has been paid to this issue. This review aimed to highlight the importance of long-term consequences and pleiotropic alterations in glucose metabolism following COVID-19 and emphasize the need for basic and clinical research in metabolism and endocrinology. Results: SARS-CoV-2 shifts cellular metabolism from oxidative phosphorylation to glycolysis, which leads to a decrease in ATP generation. Together with metabolic imbalance, the impaired immune system elevates the susceptibility of patients with diabetes to this deadly virus. SARS-CoV-2-induced metabolic alterations in immune cells can result in hyper inflammation and a cytokine storm. Metabolic dysfunction may affect therapies against SARS-CoV-2 infection. The effective control of metabolic complications could prove useful therapeutic targets for combating COVID-19. It is also necessary to understand the long-term consequences that will affect patients with diabetes who survived COVID-19. Conclusions: Since the pathophysiology of COVID-19 is still mostly unknown, identifying the metabolic mechanisms contributing to its progression is essential to provide specific ways to prevent and improve this dangerous virus’s detrimental effects. The findings show that the new virus may induce new-onset diabetes with uncertain metabolic and clinical features, supporting a potential role of COVID-19 in the development of diabetes.
- Published
- 2021
28. Risk factors for fragility fractures in type 1 diabetes
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Angelo Lauria Pantano, Anna Rita Maurizi, Silvia Manfrini, Andrea Palermo, Ann V. Schwartz, Dario Pitocco, Concetta Suraci, Paolo Pozzilli, Nicola Napoli, Maria Altomare, Caterina Conte, Ernesto Maddaloni, Giulia Leanza, Rocky Strollo, Leanza, G., Maddaloni, E., Pitocco, D., Conte, C., Palermo, A., Maurizi, A. R., Pantano, A. L., Suraci, C., Altomare, M., Strollo, R., Manfrini, S., Pozzilli, P., Schwartz, A. V., and Napoli, N.
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Research design ,medicine.medical_specialty ,Histology ,Complications ,Physiology ,Endocrinology, Diabetes and Metabolism ,Renal function ,Disease ,Fragility ,Internal medicine ,Glucose control ,medicine ,Glycemic ,Type 1 diabetes ,business.industry ,Poor glycemic control ,Settore MED/13 - ENDOCRINOLOGIA ,medicine.disease ,Increased risk ,Fracture ,Risk factors ,Risk factor ,business ,Complication ,Fractures ,complications ,fractures ,glucose control ,risk factors ,type 1 diabetes - Abstract
Objective: To determine clinical diabetes-related risk factors for fragility fractures in type 1 diabetes (T1D). Research design and methods: History of bone fragility fractures occurring after T1D diagnosis was assessed by questionnaire in this cross-sectional study in 600 T1D subjects. Glycated hemoglobin A1c (HbA1c)over the previous 5 years was used as an index of long-term glycemic control; complications were adjudicated by physician assessment. Multinomial logistic regression models were used to assess the associations between diabetes-related risk factors and fracture history. Results: One-hundred-eleven patients (18.5%)reported at least one fracture; of these 73.8% had only one and 26.2% had more than one fracture. Average age was 41.9 ± 12.8 years, with even gender distribution; disease duration was 19.9 ± 12.0 years; and BMI was 24.4 ± 3.7 kg/m2. The 5-year average HbA1c was 7.6 ± 1.0% (60 mmol/mol). In adjusted models, reduced risk for 1 fracture was found in those with higher creatinine clearance rate (CCr)(RRR 0.22 [95% CI: 0.06–0.83]for 1 unit increase in lnCCr, p = 0.03)and increased risk in those with neuropathy (RRR 2.57 [1.21–5.46], p = 0.01). Increased risk for ≥2 fractures was found in subjects in the highest tertile of HbA1c (≥7.9%)compared with the lowest tertile (≤7.17%)(RRR 3.50 [1.04–11.7], p = 0.04)and of disease duration (≥26 years versus
- Published
- 2019
29. Vitamin D and Diabetes Mellitus
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Caterina Conte, Nicola Napoli, Ernesto Maddaloni, Ilaria Cavallari, Giustina A, Bilezikian JP., Maddaloni, E, Cavallari, I, Napoli, N, and Conte, C
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Type 1 diabetes ,business.industry ,030209 endocrinology & metabolism ,Type 2 diabetes ,030204 cardiovascular system & hematology ,medicine.disease ,Bioinformatics ,law.invention ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,Randomized controlled trial ,law ,Diabetes mellitus ,medicine ,Vitamin D and neurology ,Glucose homeostasis ,business - Abstract
Vitamin D has been suggested as a protective compound for diabetes mellitus. Several mechanisms linking vitamin D to the regulation of the immune response support a role for vitamin D in the pathogenesis of autoimmune diabetes. Epidemiological evidence and observational studies suggesting that adequate vitamin D status is related to decreased risk of developing type 1 diabetes further corroborates this concept. However, only few and mostly underpowered randomized clinical trials have been conducted to test the effectiveness of vitamin D supplementation in autoimmune diabetes, with disappointing results. Similarly, recent evidence linking vitamin D action to insulin secretion and sensitivity led to the hypothesis that this compound may play a key role in the regulation of glucose homeostasis in both pre-diabetes and overt type 2 diabetes (T2D). However, the main clinical trials evaluating the efficacy of vitamin D supplementation for the control of glucose homeostasis in people at risk for or affected by T2D have yielded inconsistent results. The aim of this review is to summarize the rationale and results of randomized clinical trials testing vitamin D and its analogs in both autoimmune and T2D.
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- 2018
30. Rethinking weight loss treatments as cardiovascular medicine in obesity, a comprehensive review.
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Tuccinardi D, Watanabe M, Masi D, Monte L, Meffe LB, Cavallari I, Nusca A, Maddaloni E, Gnessi L, Napoli N, Manfrini S, and Grigioni F
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- Humans, Heart Disease Risk Factors, Risk Factors, Bariatric Surgery, Risk Assessment, Obesity complications, Obesity therapy, Obesity epidemiology, Cardiovascular Diseases etiology, Cardiovascular Diseases epidemiology, Cardiovascular Diseases therapy, Weight Loss
- Abstract
The global escalation of obesity has made it a worldwide health concern, notably as a leading risk factor for cardiovascular disease (CVD). Extensive evidence corroborates its association with a range of cardiac complications, including coronary artery disease, heart failure, and heightened vulnerability to sudden cardiac events. Additionally, obesity contributes to the emergence of other cardiovascular risk factors including dyslipidaemia, type 2 diabetes, hypertension, and sleep disorders, further amplifying the predisposition to CVD. To adequately address CVD in patients with obesity, it is crucial to first understand the pathophysiology underlying this link. We herein explore these intricate mechanisms, including adipose tissue dysfunction, chronic inflammation, immune system dysregulation, and alterations in the gut microbiome.Recent guidelines from the European Society of Cardiology underscore the pivotal role of diagnosing and treating obesity to prevent CVD. However, the intricate relationship between obesity and CVD poses significant challenges in clinical practice: the presence of obesity can impede accurate CVD diagnosis while optimizing the effectiveness of pharmacological treatments or cardiac procedures requires meticulous adjustment, and it is crucial that cardiologists acknowledge the implications of excessive weight while striving to enhance outcomes for the vulnerable population affected by obesity. We, therefore, sought to overcome controversial aspects in the clinical management of heart disease in patients with overweight/obesity and present evidence on cardiometabolic outcomes associated with currently available weight management interventions, with the objective of equipping clinicians with an evidence-based approach to recognize and address CVD risks associated with obesity., Competing Interests: Conflict of interest: All the authors have no conflict of interest to declare., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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31. No Differences in Kidney Function Decline Between People With Type 2 Diabetes Starting a Sodium-Glucose Cotransporter 2 Inhibitor or a Glucagon-like Peptide-1 Receptor Agonist: A Real-world Retrospective Comparative Observational Study.
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Bodini S, Pieralice S, D'Onofrio L, Mignogna C, Coraggio L, Amendolara R, Risi R, Salducci M, Buzzetti R, and Maddaloni E
- Abstract
Purpose: Diabetic nephropathy represents the leading cause of end-stage kidney disease in developed countries. Cardiovascular outcome trials have found that in participants who received a glucagon-like peptide-1 receptor agonist (GLP1RA) and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), the risk of incidence and progression of diabetic nephropathy in type 2 diabetes mellitus was reduced. The aim of this study was to compare the decline in estimated glomerular filtration rate (eGFR) among people taking a GLP1RA with that among people taking an SGLT2i in a real-world setting., Methods: Data for 478 patients with type 2 diabetes mellitus who initiated therapy with a GLP1RA (n = 254) or an SGLT2i (n = 224) between January 1, 2018 and December 31, 2021 were extracted. The primary outcome was any reduction ≥30% in eGFR after the start of therapy. Weight loss and drug discontinuation were also assessed., Findings: Over a median follow-up of 24 months, an eGFR reduction ≥30% occurred in 34 of 254 patients (13.4%) starting a GLP1RA and in 26 of 223 patients (11.6%) starting an SGLT2i (hazard ratio = 0.89; 95% CI, 0.54-1.49; P = 0.67). Median eGFR change over the whole follow-up was similar between groups (SGLT2i: median, -2 mL/min/1.73 m
2 ; 25th, 75th percentile, -13, 8 mL/min/1.73 m2 ; GLP1RA: median, 0 mL/min/1.73 m2 ; 25th, 75th percentile, -10, 7 mL/min/1.73 m2 ; P = 0.54). No worsening of kidney function was observed, even when considering the ratio eGFR mean. The value of eGFR at baseline indicated a statistically significant indirect correlation with the observed absolute value of eGFR change over the follow-up (ρ = -0.36; P < 0.001). The difference in eGFR changes over time observed by eGFR categories was statistically significant (P = 0.0001) in both treatment groups. No significant differences in weight loss and drug discontinuations were observed between groups., Implications: Although acting on different molecular mechanisms, both GLP1RA and SGLT2i might have similar effects on eGFR decline in diabetes, as suggested by the results of the present study conducted in a real-world setting. (Clin Ther. 2024;46:XXX-XXX) © 2024 Elsevier HS Journals, Inc., Competing Interests: Declaration of competing interest E. Maddaloni reported personal speaker/consultancy fees from PikDare, Abbott, MTD, MSD, EliLilly, NovoNordisk, and Merck-Serono KgA and support for attending scientific meetings from Abbott and Theras. R. Buzzetti reported research grants from AstraZeneca and speaker/consultancy fees from EliLilly, Sanofi, Abbott, Vertex, NovoNordisk, Boehringer Ingheleim, AstraZeneca, Mundipharma, and Guidotti. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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32. Obesity in type 1 diabetes: an overlooked immune-metabolic issue.
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Maddaloni E and Tuccinardi D
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- Humans, Diabetes Mellitus, Type 1 immunology, Diabetes Mellitus, Type 1 complications, Obesity complications, Obesity immunology
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- 2024
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33. Saxagliptin/dapagliflozin is non-inferior to insulin glargine in terms of β-cell function in subjects with latent autoimmune diabetes in adults: A 12-month, randomized, comparator-controlled pilot study.
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Maddaloni E, Naciu AM, Mignogna C, Galiero R, Amendolara R, Fogolari M, Satta C, Serafini C, Angeletti S, Cavallo MG, Cossu E, Sasso FC, Buzzetti R, and Pozzilli P
- Subjects
- Adult, Humans, Insulin Glargine adverse effects, Glycated Hemoglobin, C-Peptide, Pilot Projects, Blood Glucose, Treatment Outcome, Hypoglycemic Agents adverse effects, Double-Blind Method, Drug Therapy, Combination, Diabetes Mellitus, Type 2 drug therapy, Latent Autoimmune Diabetes in Adults, Metformin therapeutic use, Adamantane analogs & derivatives, Benzhydryl Compounds, Dipeptides, Glucosides
- Abstract
Aim: To compare the efficacy and safety of saxagliptin/dapagliflozin and insulin glargine in people with latent autoimmune diabetes in adults (LADA)., Methods: In this phase 2b multicentre, open-label, comparator-controlled, parallel-group, non-inferiority study, we randomly assigned 33 people with LADA who had a fasting C-peptide concentration ≥0.2 nmol/L (0.6 ng/mL) to receive 1-year daily treatment with either the combination of saxagliptin (5 mg) plus dapagliflozin (10 mg) or insulin glargine (starting dose: 10 IU), both on top of metformin. The primary outcome was the 2-h mixed meal-stimulated C-peptide area under the curve (AUC), measured 12 months after randomization. Secondary outcomes were glycated haemoglobin (HbA1c) levels, change in body mass index (BMI), and hypoglycaemic events., Results: In the modified intention-to-treat analysis, the primary outcome was similar in participants assigned to saxagliptin/dapagliflozin or to insulin glargine (median C-peptide AUC: 152.0 ng*min/mL [95% confidence interval {CI} 68.2; 357.4] vs. 122.2 ng*min/mL [95% CI 84.3; 255.8]; p for noninferiority = 0.0087). Participants randomized to saxagliptin/dapagliflozin lost more weight than those randomized to insulin glargine (median BMI change at the end of the study: -0.4 kg/m
2 [95% CI -1.6; -0.3] vs. +0.4 kg/m2 [95% CI -0.3; +1.1]; p = 0.0076). No differences in HbA1c or in the number of participants experiencing hypoglycaemic events were found., Conclusions: Saxagliptin/dapagliflozin was non-inferior to glargine in terms of β-cell function in this 12-month, small, phase 2b study, enrolling people with LADA with still viable endogenous insulin production. Weight loss was greater with saxagliptin/dapagliflozin, with no differences in glycaemic control or hypoglycaemic risk., (© 2024 John Wiley & Sons Ltd.)- Published
- 2024
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34. Immune checkpoint modulators in early clinical development for the treatment of type 1 diabetes.
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Maddaloni E, Amendolara R, Balena A, Latino A, Sessa RL, and Buzzetti R
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- Humans, Quality of Life, Immunotherapy methods, Autoimmunity, Insulin metabolism, Immunologic Factors therapeutic use, Diabetes Mellitus, Type 1 drug therapy
- Abstract
Introduction: Despite the improvements of insulin therapy, people with type 1 diabetes (T1D) still suffer from a decreased quality of life and life expectancy. The search toward a cure for T1D is therefore still a scorching open field of research., Areas Covered: Tackling the immune checkpoint signaling pathways has gained importance in the field of cancer immunotherapy. The same pathways can be targeted in autoimmunity with an opposite principle: to dampen the exaggerated immune response. In this review, we report a comprehensive excursus on the cellular and molecular mechanisms that lead to loss of immunological tolerance, and recent evidence on the role of immune checkpoint molecules in the development of T1D and their potential application for the mitigation of autoimmune diabetes., Expert Opinion: Contrasting results about the efficacy of immune checkpoint modulators for T1D have been published, with very few molecules from preclinical studies eligible for use in humans. The heterogeneous and complex pathophysiology of T1D may explain the conflicting evidence. Designing clinical trials that acknowledge the pathophysiological and clinical complexity of T1D and that forecast the need of simultaneously tackling different disease pathways will be crucial to enhance the benefits which may be gained by such compounds.
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- 2024
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35. Glycated haemoglobin in the first year after diagnosis of type 1 diabetes is an independent risk factor for diabetic retinopathy: The IMDIAB 25 years follow-up study.
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Maddaloni E, Carlone A, Pitocco D, Leanza G, Suraci C, Altomare M, Cavallo MG, Barchetta I, Morano S, Moretti C, Coraggio L, Visalli N, Tramontana F, Schiaffini R, Crinò A, Buzzetti R, and Pozzilli P
- Subjects
- Humans, Glycated Hemoglobin, Follow-Up Studies, Risk Factors, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 epidemiology, Diabetes Mellitus, Type 1 diagnosis, Diabetic Retinopathy diagnosis, Diabetic Retinopathy epidemiology, Diabetic Retinopathy etiology
- Published
- 2023
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36. Lack of Association between Serum Chitotriosidase Activity and Arterial Stiffness in Type 2 Diabetes without Cardiovascular Complications.
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D'Onofrio L, Amendolara R, Mignogna C, Leto G, Tartaglione L, Mazzaferro S, Maddaloni E, and Buzzetti R
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- Humans, Pulse Wave Analysis adverse effects, Cross-Sectional Studies, Risk Factors, Diabetes Mellitus, Type 2, Vascular Stiffness physiology, Cardiovascular Diseases
- Abstract
Chitotriosidase (CHIT), a mammalian chitinase secreted by neutrophils and activated macrophages, is increased in both cardiovascular disease (CVD) and type 2 diabetes (T2D). Arterial stiffness rises early in T2D and increases the risk of CVD. The aim of this study is to evaluate CHIT activity as an early biomarker of arterial stiffness in people with T2D free from overt vascular complications. In this cross-sectional study, arterial stiffness as measured using standard pulse wave velocity (PWV) was evaluated in 174 people with T2D without overt vascular disease. Then, we measured CHIT serum activity with an electrochemiluminescence assay in two subgroups of participants: 35 with the highest (high-PWV) and 40 with the lowest (low-PWV) PWV values. CHIT activity was no different between the low-PVW and high-PWV groups (12.7 [9.6-17.9] vs. 11.4 [8.8-15.0] nmol/mL/h, respectively). Compared with the low-PWV group, the high-PWV participants were older ( p < 0.001); had a longer duration of diabetes ( p = 0.03); higher ankle-brachial index ABI ( p = 0.04), systolic blood pressure ( p = 0.002), diastolic blood pressure ( p = 0.005), fasting blood glucose ( p = 0.008), and HbA1c ( p = 0.005); and lower eGFR ( p = 0.03) and body mass index (BMI) ( p = 0.01). No association was present with sex, duration of diabetes, age, BMI, peripheral blood pressure, laboratory parameters, and glucose-lowering medications or ongoing antihypertensive therapy. Although no association was found, this study provides novel data about the association of CHIT activity with CVD, focusing on a specific outcome (arterial stiffness) in a well-defined population of subjects with T2D without established CVD.
- Published
- 2023
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37. Association of osteocalcin, osteoprotegerin, and osteopontin with cardiovascular disease and retinopathy in type 2 diabetes.
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Maddaloni E, Coraggio L, Amendolara R, Baroni MG, Cavallo MG, Copetti M, Cossu E, D'Angelo P, D'Onofrio L, Cosmo S, Leonetti F, Morano S, Morviducci L, Napoli N, Prudente S, Pugliese G, Park K, Holman RR, Trischitta V, and Buzzetti R
- Subjects
- Humans, Osteopontin, Osteocalcin, Biomarkers, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Vascular Diseases, Diabetic Retinopathy epidemiology, Diabetic Retinopathy etiology
- Abstract
Background: Novel biomarkers of vascular disease in diabetes could help identify new mechanistic pathways. Osteocalcin, osteoprotegerin, and osteopontin are key molecules involved in bone and vascular calcification processes, both of which are compromised in diabetes. We aimed to evaluate possible associations of osteocalcin, osteoprotegerin, and osteopontin with cardiovascular disease (CVD) and diabetic retinopathy (DR) among people with type 2 diabetes (T2D)., Materials and Methods: Osteocalcin, osteoprotegerin, and osteopontin concentrations were measured at enrolment in 848 participants with T2D from the Sapienza University Mortality and Morbidity Event Rate (SUMMER) Study (ClinicalTrials.gov: NCT02311244). Logistic regression models and propensity score matching were used to assess possible associations of osteocalcin, osteoprotegerin, and osteopontin with a history of CVD and with evidence of any grade of DR adjusting for confounders., Results: Previous CVD was reported in 139 (16.4%) participants, while 144 (17.0%) had DR. After adjusting for possible confounders, osteocalcin but not osteoprotegerin or osteopontin concentrations were associated with a history of CVD (Odds Ratio [OR] and 95% CI for one standard deviation (SD) increase in osteocalcin concentrations (natural log): 1.35 (1.06-1.72), p = 0.014). Associations with prevalent DR were seen for osteoprotegerin (OR for one SD increase in osteoprotegerin concentrations (natural log): 1.25 (1.01-1.55), p = 0.047) and osteopontin (OR for one SD increase in osteopontin concentrations (natural log): 1.25 (1.02-1.53), p = 0.022), but not osteocalcin., Conclusions: In T2D, higher serum osteocalcin concentrations are associated with macrovascular complications and higher osteoprotegerin and osteopontin concentrations with microvascular complications, suggesting that these osteokines might be involved in pathways directly related to vascular disease., (© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)
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- 2023
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38. Updates on Glycaemic Control Strategies: A Range of Opportunities after Total Pancreatectomy.
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Pieralice S, Coppola A, and Maddaloni E
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In the past, indications for total pancreatectomy (TP) were rare, with several concerns about patients' postoperative quality of life due to exocrine and endocrine post-pancreatectomy management [...].
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- 2023
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39. Impact of baseline kidney function on the effects of sodium-glucose co-transporter-2 inhibitors on kidney and heart failure outcomes: A systematic review and meta-analysis of randomized controlled trials.
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Maddaloni E, Cavallari I, La Porta Y, Appetecchia A, D'Onofrio L, Grigioni F, Buzzetti R, and Holman RR
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- Humans, Disease Progression, Glomerular Filtration Rate, Kidney, Randomized Controlled Trials as Topic, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Heart Failure epidemiology, Heart Failure prevention & control, Kidney Diseases, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Sodium-Glucose Transporter 2 Inhibitors pharmacology
- Abstract
Aim: To determine whether the magnitude of the cardiorenal benefits of sodium-glucose co-transporter-2 inhibitors (SGLT2is) varies with baseline kidney function., Methods: We searched randomized, placebo-controlled trials testing the effects of SGLT2is on renal and cardiovascular outcomes. Efficacy outcomes, stratified by baseline estimated glomerular filtration rate (eGFR) categories, included renal disease progression, a composite heart failure (HF) outcome and mortality., Results: Thirteen trials testing SGLT2is in 90 402 participants with available eGFR data were included. The risk of bias was judged as low for all trials. SGLT2is reduced the relative risks of renal disease progression by 27% to 57% and of HF outcomes by 13% to 32% across different eGFR categories, with an overall low heterogeneity. Meta-regression analyses showed a significant direct relationship between baseline eGFR and the magnitude of SGLT2is' renal protection (P = .003). The greatest risk reduction was in participants with an eGFR of 90 ml/min/1.73m
2 or higher (HR 0.43, 95% CI: 0.32-0.58) and the smallest was in those with an eGFR of less than 30 ml/min/1.73m2 (HR 0.73, 95% CI: 0.62-0.86, P < .001). Conversely, for HF, the greatest risk reduction was in those with an eGFR of less than 30 ml/min/1.73m2 (HR 0.68, 95% CI: 0.48-0.96) and the smallest was in those with an eGFR of 90 ml/min/1.73m2 or higher (HR 0.87, 95% CI: 0.56-1.34)., Conclusions: SGLT2is reduce the risk of renal and HF outcomes for all eGFR categories. The greatest benefits in terms of kidney protection may be achieved by early initiation of SGLT2is in people with preserved eGFR. The greatest risk reduction for HF outcomes is observed in people with lower eGFR values., (© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)- Published
- 2023
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40. Relationship between Muscle Mass, Bone Density and Vascular Calcifications in Elderly People with SARS-CoV-2 Pneumonia.
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Del Toro R, Palmese F, Feletti F, Zani G, Minguzzi MT, Maddaloni E, Napoli N, Bedogni G, and Domenicali M
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Background: Little is known about the changes in organs and tissues that may make elder patients more vulnerable to acute stressors such as SARS-CoV-2 infection., Methods: In 80 consecutive elderly patients with SARS-CoV-2 infection, we evaluated the association between the descending thoracic aorta calcium score, L1 bone density and T12 skeletal muscle density measured on the same scan by high-resolution computed tomography., Results: At median regression, the ln-transformed DTA calcium score was inversely associated with L1 bone density (-0.02, 95%CI -0.04 to -0.01 ln-Agatston units for an increase of 1 HU) and with T12 muscle density (-0.03, -0.06 to -0.001 ln-Agatston units for an increase of 1 HU). At penalized logistic regression, an increase of 1 ln-Agatston unit of DTA calcium score was associated with an OR of death of 1.480 (1.022 to 2.145), one of 1 HU of bone density with an OR of 0.981 (0.966 to 0.996) and one of 1 HU of muscle density with an OR of 0.973 (0.948 to 0.999). These relationships disappeared after correction for age and age was the stronger predictor of body composition and death., Conclusions: Age has a big effect on the relationship between vascular calcifications, L1 bone density and T12 muscle density and on their relationship with the odds of dying.
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- 2023
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41. Reduced early response to SARS-CoV2 vaccination in people with type 1 and type 2 diabetes, a 6 months follow-up study: The CoVaDiab study I.
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D'Onofrio L, Fogolari M, Amendolara R, Siena A, De Fata R, Davini F, Coraggio L, Mignogna C, Moretti C, Maddaloni E, Angeletti S, and Buzzetti R
- Subjects
- Male, Female, Humans, Follow-Up Studies, RNA, Viral, COVID-19 Vaccines, SARS-CoV-2, Vaccination, Antibodies, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 1, COVID-19 prevention & control
- Abstract
Introduction: Diabetes mellitus worsens the prognosis of SARS-CoV-2 infection, and vaccination has been the major tool for reducing the risk of hospitalisation, and mortality. The primary aim of this study was to evaluate the response to the SARS-CoV-2 vaccine in subjects with diabetes and controls. Differences between type 1 (T1D) and type 2 (T2D) diabetes and clinical determinants of vaccination response were also evaluated., Methods: 128 subjects with diabetes (60 with T1D and 62 with T2D) and 202 subjects acting as controls who completed a full vaccination cycle with two doses of mRNA vaccine were enroled. People with previous SARS-CoV-2 infection were excluded. Antibodies (Ab) directed against the spike protein of the SARS-CoV-2 were evaluated at one and 6 months after vaccination., Results: In the whole cohort, the Ab level was higher among women than in men (p = 0.011) and negatively correlated with age (rho = -0.155, p = 0.005). Subjects with diabetes showed decreased levels of Ab after one month compared to controls (1217[747-1887]BAU/mL vs. 1477[942-2556]BAU/mL, p = 0.002), even after correction for age and gender (p = 0.002). No difference was found between subjects with T1D and T2D. After 6 months, antibody levels significantly decreased in people with and without diabetes, with no differences between groups, although some subjects were lost at follow-up. In subjects with diabetes, only a significant correlation was found between Ab level and renal function (rho 0.190, p = 0.042)., Conclusions: Both T1D and T2D are associated with a reduced early response to vaccination. The serum concentration of Ab significantly reduced over time in both groups, highlighting the relevance of vaccination boosters independently of the presence of diabetes., (© 2022 John Wiley & Sons Ltd.)
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- 2023
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42. C-peptide determination in the diagnosis of type of diabetes and its management: A clinical perspective.
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Maddaloni E, Bolli GB, Frier BM, Little RR, Leslie RD, Pozzilli P, and Buzzetti R
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- Adult, Biomarkers metabolism, C-Peptide, Humans, Insulin metabolism, Insulin therapeutic use, Insulin Secretion, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 1 therapy, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 therapy
- Abstract
Impaired beta-cell function is a recognized cornerstone of diabetes pathophysiology. Estimates of insulin secretory capacity are useful to inform clinical practice, helping to classify types of diabetes, complication risk stratification and to guide treatment decisions. Because C-peptide secretion mirrors beta-cell function, it has emerged as a valuable clinical biomarker, mainly in autoimmune diabetes and especially in adult-onset diabetes. Nonetheless, the lack of robust evidence about the clinical utility of C-peptide measurement in type 2 diabetes, where insulin resistance is a major confounder, limits its use in such cases. Furthermore, problems remain in the standardization of the assay for C-peptide, raising concerns about comparability of measurements between different laboratories. To approach the heterogeneity and complexity of diabetes, reliable, simple and inexpensive clinical markers are required that can inform clinicians about probable pathophysiology and disease progression, and so enable personalization of management and therapy. This review summarizes the current evidence base about the potential value of C-peptide in the management of the two most prevalent forms of diabetes (type 2 diabetes and autoimmune diabetes) to address how its measurement may assist daily clinical practice and to highlight current limitations and areas of uncertainties to be covered by future research., (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
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- 2022
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43. Adult-onset autoimmune diabetes.
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Buzzetti R, Maddaloni E, Gaglia J, Leslie RD, Wong FS, and Boehm BO
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- Adult, Biomarkers, Child, Humans, Insulin therapeutic use, Quality of Life, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy
- Abstract
Adult-onset autoimmune (AOA) diabetes pathophysiology starts with immune changes, followed by dysglycaemia and overt disease. AOA diabetes can occur as classic type 1 diabetes when associated with severe loss of insulin secretion. More frequently, it is diagnosed as latent autoimmune diabetes in adults, a slowly progressing form with late onset, a long period not requiring insulin, and it is often misdiagnosed as type 2 diabetes. As its clinical presentation varies remarkably and immune markers often lack specificity, it is challenging to classify each case ad hoc, especially when insulin treatment is not required at diagnosis. Proper care of AOA diabetes aims to prevent complications and to improve quality of life and life expectancy. To achieve these goals, attention should be paid to lifestyle factors, with the aid of pharmacological therapies properly tailored to each individual clinical setting. Given the heterogeneity of the disease, choosing the right therapy for AOA diabetes is challenging. Most of the trials testing disease-modifying therapies for autoimmune diabetes are conducted in people with childhood onset, whereas non-insulin diabetes therapies have mostly been studied in the larger population with type 2 diabetes. More randomized controlled trials of therapeutic agents in AOA diabetes are needed., (© 2022. Springer Nature Limited.)
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- 2022
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44. The Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Reduce Platelet Activation and Thrombus Formation by Lowering NOX2-Related Oxidative Stress: A Pilot Study.
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Pignatelli P, Baratta F, Buzzetti R, D'Amico A, Castellani V, Bartimoccia S, Siena A, D'Onofrio L, Maddaloni E, Pingitore A, Chiariello GA, Santilli F, Pastori D, Cocomello N, Violi F, Del Ben M, Cammisotto V, and Carnevale R
- Abstract
Sodium−glucose co-transporter-2 inhibitors or gliflozins, the newest anti-hyperglycemic class, induce cardioprotective benefits in patients with type 2 diabetes (T2D). As platelet activation and oxidative stress play a key role in atherothrombotic-related complications, we hypothesized that gliflozins might modulate oxidative stress, platelet activation and thrombus formation. We performed an interventional open-label single-arm before-after study in 32 T2D patients on top of their ongoing metformin therapy. The population was divided into two groups: treatment with GLP-1 receptor agonists (GLP-1RA, Group A) and gliflozins (Group B). Oxidative stress, platelet activation and thrombus growth were assessed before and after 15 days of treatment. Compared to the baseline, gliflozins treatment significantly decreased sNOX2-dp (−45.2%, p < 0.001), H2O2 production (−53.4%, p < 0.001), TxB2 (−33.1%, p < 0.001), sP-selectin (−49.3%, p < 0.001) and sCD40L levels (−62.3%, p < 0.001) as well as thrombus formation (−32%, p < 0.001), whereas it potentiated anti-oxidant power (HBA, +30.8%, p < 0.001). Moreover, a significant difference in oxidative stress, platelet activation and thrombus formation across groups A and B was found. In addition, an in vitro study on stimulated platelets treated with gliflozins (10−30 μM) showed a reduction in oxidative stress, platelet activation and thrombus growth. Our results showed that gliflozins have antiplatelet and antithrombic activity related to an NOX2 down-regulation, suggesting a new mechanism responsible for cardiovascular protection.
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- 2022
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45. Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study.
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Defeudis G, Maddaloni E, Rossini G, Di Tommaso AM, Mazzilli R, Di Palma P, Pozzilli P, and Napoli N
- Abstract
Background: This is a proof of concept, as a pilot study, with the aim to evaluate continuous glucose monitoring metrics (CGM) in subjects with type 2 diabetes (T2DM), treated with nutritional therapy and metformin, before and after testosterone replacement therapy (TRT)., Methods: In this longitudinal observational study, subjects affected by T2DM and starting TRT for documented ED and hypogonadism were enrolled. All subjects mounted a CGM system during the v0 visit, one week before the beginning of the TRT (week-1), during v2, four weeks after the start of TRT (week 4), and v4 (week 12). CGM was worn for about 144 h after each visit., Results: A total of seven patients, referring to our clinic for erectile dysfunction (ED), were studied (aged 63.3 ± 2.3 years). Mean (± standard deviation) total testosterone level was 2.3 ± 0.6 ng/mL at baseline. After TRT, total testosterone level was 4.6 ± 3.04 ng/mL at week 4 and 3.93 ± 4.67 ng/mL at week 12. No significant differences were observed in TIR, TAR, TBR, estimated HbA1c, AUC below, and AUC above limit during the intervention period., Conclusions: This is the first study evaluating the effects of TRT on daily glucose excursions in subjects with T2DM and hypogonadism. Though we did not find any significant difference in key CGM metrics during the 12 weeks of TRT, this study confirms the glycometabolic safety of the TRT even on the most novel standardized glycemic targets.
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- 2022
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46. Questions and answers on the use of aspirin for primary prevention of cardiovascular disease in diabetes.
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Cavallari I, Nobile E, De Filippis A, Veneziano F, Maddaloni E, Ussia GP, and Grigioni F
- Subjects
- Humans, Primary Prevention methods, Risk Assessment, Aspirin adverse effects, Cardiovascular Diseases prevention & control, Diabetes Mellitus drug therapy
- Abstract
Patients with diabetes have a prothrombotic state and a 2 to 4 times higher risk of cardiovascular events than those without diabetes. Aspirin is the cornerstone of treatment in patients withcardiovascular disease, irrespective of diabetes status, being able to confer a 19% relative risk reduction per year in serious vascular events compared with placebo at long-term follow-up (6.7% vs 8.2% per year, p < 0.0001). Data regarding the benefit-risk ratio of aspirin prescribed to patients with diabetes without established cardiovascular disease are less convincing, especially when compared to other preventive strategies. Of note, in primary prevention trials, aspirin allocation yielded a significant 12% proportional reduction in serious vascular events, irrespective of diabetes status, corresponding to a small annual absolute risk reduction (0.06% per year). However, in everyday clinical practice aspirin is still largely prescribed by both diabetologists and cardiologists. In this article, we provide eight questions and answers corroborated by available evidence on the use of aspirin for primary prevention of cardiovascular disease in diabetes., 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 B.V. All rights reserved.)
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- 2022
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47. Diastolic Pressure and ACR Are Modifiable Risk Factors of Arterial Stiffness in T2DM Without Cardiovascular Disease.
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Leto G, Tartaglione L, Rotondi S, Pasquali M, Maddaloni E, Mignogna C, D'Onofrio L, Zampetti S, Carlone A, Muci ML, Mastroluca D, Fassino V, Buzzetti R, and Mazzaferro S
- Subjects
- Biomarkers, Blood Pressure physiology, Female, Humans, Male, Middle Aged, Risk Factors, Cardiovascular Diseases complications, Cardiovascular Diseases etiology, Diabetes Mellitus, Type 2 complications, Renal Insufficiency, Chronic complications, Vascular Stiffness physiology
- Abstract
Aim: To evaluate early, before the onset of cardiovascular events and of chronic renal insufficiency, the association between chronic kidney disease (CKD)-mineral bone disorder (MBD) biomarkers and vascular stiffness [Cardio Ankle Vascular Index (CAVI)] in the course of type 2 diabetes (T2DM)., Method: We evaluated 174 T2DM patients [median age 56 years; male/female (M/F) 100/74] with diabetes duration < 10 years and without decreased estimated glomerular filtration rate (eGFR; ≥60 mL/min/1.73 m2) or macrovascular complications. Thirty-four age-matched healthy subjects [M/F 13/21; age 53.5 (50.0-57.7) years; eGFR 107.5 (97.0-119.7) mL/ min1.73 m2] served as local reference control for CAVI (pathological: ≥8) and the novel CKD-MBD biomarkers., Results: Albumin-to-creatinine ratio (ACR) averaged 8.5 mg/g (5.6-17.2) with 12.6% of the patients showing pathologic values, indicative of incipient diabetic nephropathy. Serum parathyroid hormone, fibroblast growth factor 23, and sclerostin were higher while 1,25-dihydroxyvitamin D and Klotho were lower than a control group. CAVI was normal (<8) in only 54% and correlated positively with age (P < 0.001), hemoglobin 1A1c (P = 0.036), and systolic (P = 0.021) and diastolic blood pressure (DBP) (P = 0.001) and negatively correlated with 25-hydroxyvitamin D (P = 0.046). In multivariate analysis, age, DBP, ACR, and serum Klotho were independent positive predictors of CAVI., Conclusion: In the absence of overt cardiovascular disease and of chronic renal insufficiency, CAVI is frequently pathologic in T2DM. DBP and ACR are modifiable risk factors of vascular stiffness in T2DM, thus warranting optimal assessment., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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48. Endothelial Cells Induced Progenitors Into Brown Fat to Reduce Atherosclerosis.
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Park K, Li Q, Lynes MD, Yokomizo H, Maddaloni E, Shinjo T, St-Louis R, Li Q, Katagiri S, Fu J, Clermont A, Park H, Wu IH, Yu MG, Shah H, Tseng YH, and King GL
- Subjects
- Animals, Apolipoproteins E metabolism, Endothelial Cells metabolism, Insulin metabolism, Mice, Mice, Inbred C57BL, Nitric Oxide metabolism, Adipose Tissue, Brown metabolism, Atherosclerosis genetics, Atherosclerosis metabolism, Atherosclerosis prevention & control
- Abstract
Background: Insulin resistance (IR) can increase atherosclerotic and cardiovascular risk by inducing endothelial dysfunction, decreasing nitric oxide (NO) production, and accelerating arterial inflammation. The aim is to determine the mechanism by which insulin action and NO production in endothelial cells can improve systemic bioenergetics and decrease atherosclerosis via differentiation of perivascular progenitor cells (PPCs) into brown adipocytes (BAT)., Methods: Studies used various endothelial transgenic and deletion mutant ApoE
-/- mice of insulin receptors, eNOS (endothelial NO synthase) and ETBR (endothelin receptor type B) receptors for assessments of atherosclerosis. Cells were isolated from perivascular fat and micro-vessels for studies on differentiation and signaling mechanisms in responses to NO, insulin, and lipokines from BAT., Results: Enhancing insulin's actions on endothelial cells and NO production in ECIRS1 transgenic mice reduced body weight and increased systemic energy expenditure and BAT mass and activity by inducing differentiation of PPCs into beige/BAT even with high-fat diet. However, positive changes in bioenergetics, BAT differentiation from PPCs and weight loss were inhibited by N(gamma)-nitro-L-arginine methyl ester (L -NAME), an inhibitor of eNOS, in ECIRS1 mice and eNOSKO mice. The mechanism mediating NO's action on PPC differentiation into BAT was identified as the activation of solubilized guanylate cyclase/PKGIα (cGMP protein-dependent kinase Iα)/GSK3β (glycogen synthase kinase 3β) pathways. Plasma lipidomics from ECIRS1 mice with NO-induced increased BAT mass revealed elevated 12,13-diHOME production. Infusion of 12,13-diHOME improved endothelial dysfunction and decreased atherosclerosis, whereas its reduction had opposite effects in ApoE- /- mice., Conclusions: Activation of eNOS and endothelial cells by insulin enhanced the differentiation of PPC to BAT and its lipokines and improved systemic bioenergetics and atherosclerosis, suggesting that endothelial dysfunction is a major contributor of energy disequilibrium in obesity.- Published
- 2022
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49. Development of a clinical risk score to predict death in patients with COVID-19.
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Alhamar G, Maddaloni E, Al Shukry A, Al-Sabah S, Al-Haddad M, Al-Youha S, Jamal M, Almazeedi S, Al-Shammari AA, Abu-Farha M, Abubaker J, Alattar AT, AlOzairi E, Alessandri F, D'Onofrio L, Leto G, Mastroianni CM, Mignogna C, Pascarella G, Pugliese F, Ali H, Al Mulla F, Buzzetti R, and Pozzilli P
- Subjects
- Glucose, Hospital Mortality, Humans, Prognosis, ROC Curve, Retrospective Studies, Risk Factors, COVID-19
- Abstract
Objective: To build a clinical risk score to aid risk stratification among hospitalised COVID-19 patients., Methods: The score was built using data of 417 consecutive COVID-19 in patients from Kuwait. Risk factors for COVID-19 mortality were identified by multivariate logistic regressions and assigned weighted points proportional to their beta coefficient values. A final score was obtained for each patient and tested against death to calculate an Receiver-operating characteristic curve. Youden's index was used to determine the cut-off value for death prediction risk. The score was internally validated using another COVID-19 Kuwaiti-patient cohort of 923 patients. External validation was carried out using 178 patients from the Italian CoViDiab cohort., Results: Deceased COVID-19 patients more likely showed glucose levels of 7.0-11.1 mmol/L (34.4%, p < 0.0001) or >11.1 mmol/L (44.3%, p < 0.0001), and comorbidities such as diabetes and hypertension compared to those who survived (39.3% vs. 20.4% [p = 0.0027] and 45.9% vs. 26.6% [p = 0.0036], respectively). The risk factors for in-hospital mortality in the final model were gender, nationality, asthma, and glucose categories (<5.0, 5.5-6.9, 7.0-11.1, or 11.1 > mmol/L). A score of ≥5.5 points predicted death with 75% sensitivity and 86.3% specificity (area under the curve (AUC) 0.901). Internal validation resulted in an AUC of 0.826, and external validation showed an AUC of 0.687., Conclusion: This clinical risk score was built with easy-to-collect data and had good probability of predicting in-hospital death among COVID-19 patients., (© 2022 John Wiley & Sons Ltd.)
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- 2022
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50. Immunoreactivities Against Different Tyrosine-Phosphatase 2 (IA-2)(256-760) Protein Domains Characterize Distinct Phenotypes in Subjects With LADA.
- Author
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Tiberti C, D'Onofrio L, Panimolle F, Zampetti S, Maddaloni E, and Buzzetti R
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- Autoantibodies, Epitopes, Humans, Immunity, Obesity complications, Phenotype, Phosphoric Monoester Hydrolases, Protein Domains, Tyrosine, Diabetes Mellitus, Type 1 complications, Latent Autoimmune Diabetes in Adults
- Abstract
Antibodies (Abs) against intracellular epitopes of the tyrosine-phosphatase 2 (IA-2) are detected in type 1 diabetes. Abs directed against the IA-2(256-760) portion, with both intra- and extracellular epitopes, are present in people with latent autoimmune diabetes in adults (LADA) and in obese subjects with normal glucose tolerance (NGT). We aim to characterize distribution and clinical features of intra- and extra-cellular IA-2(256-760) immunoreactivities in people with LADA compared to obese people with NGT. The intracellular immunoreactivity represented by immune response against two intracellular IA-2 constructs (IA-2JM(601-630) and IA-2IC(605-979)) was analyzed and related to clinical and biochemical features in 101 people with LADA and in 20 NGT obese subjects, all testing positive for IA-2(256-760) Abs. IA-2 intracellular immunoreactivity showed a frequency of 40.6% in LADA while it was not detected among NGT obese (p<0.001). Amongst LADA, the presence of immunoreactivity against the IA-2 intracellular domains was associated with lower BMI, waist circumference, higher HDL cholesterol and lower triglycerides, lower prevalence of hypertension and higher prevalence of other autoimmune disorders. Immunoreactivity against IA-2 does not involve intracellular domains in the majority of LADA and in obese people with NGT. This study shows that there is heterogeneity in the IA-2 epitopes, associated with different clinical features., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Tiberti, D’Onofrio, Panimolle, Zampetti, Maddaloni and Buzzetti.)
- Published
- 2022
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