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1. Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

Author

Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., Protti G., Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., and Protti G.

Abstract

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's

Published
2023

2. Impaired fasting glucose and impaired glucose tolerance in children and adolescents with overweight/obesity

Author

Di Bonito, P., Pacifico, L., Chiesa, C., Valerio, G., Miraglia del Giudice, E., Maffeis, C., Morandi, A., Invitti, C., Licenziati, M. R., Loche, S., Tornese, G., Franco, F., Manco, M., Baroni, M. G., Driul, D., Grandone, A., Incani, M., Pani, M. G., Tomat, Michela, Sanguigno, E., Gilardini, L., Pellegrin, M. C., and for the “CARdiometabolic risk factors in overweight and obese children in ITALY” (CARITALY) Study Group

Published
2017
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4. Cardiovascular Risk Factors Associated With the Metabolically Healthy Obese (MHO) Phenotype Compared to the Metabolically Unhealthy Obese (MUO) Phenotype in Children

Author

Genovesi, S, Antolini, L, Orlando, A, Gilardini, L, Bertoli, S, Giussani, M, Invitti, C, Nava, E, Battaglino, M, Leone, A, Valsecchi, M, Parati, G, Genovesi S., Antolini L., Orlando A., Gilardini L., Bertoli S., Giussani M., Invitti C., Nava E., Battaglino M. G., Leone A., Valsecchi M. G., Parati G., Genovesi, S, Antolini, L, Orlando, A, Gilardini, L, Bertoli, S, Giussani, M, Invitti, C, Nava, E, Battaglino, M, Leone, A, Valsecchi, M, Parati, G, Genovesi S., Antolini L., Orlando A., Gilardini L., Bertoli S., Giussani M., Invitti C., Nava E., Battaglino M. G., Leone A., Valsecchi M. G., and Parati G.

Abstract

Background: In pediatric age the prevalence of obesity is high. Obese children who do not have other risk factors than excess weight have been defined as “metabolically healthy obese” (MHO). Aim: The aim of this study is to evaluate, in a population of obese children, the prevalence of the MHO and “metabolically unhealthy obese” (MUO) phenotype. Furthermore, we evaluated the distribution of Uric Acid, HOMA index and Waist-Height ratio (W-Hr) in the MHO and MUO sub-groups and the impact of these non-traditional risk factors on the probability to be MUO. Methods: In 1201 obese children and adolescents [54% males, age (±SD) 11.9 (±3.0) years] weight, height, waist circumference, systolic (SBP) and diastolic (DBP) blood pressure, pubertal status, glucose, insulin, HDL cholesterol, triglycerides and Uric Acid serum values were assessed. MUO phenotype was defined as the presence of at least one of the following risk factors: SBP or DBP ≥ 90th percentile, glycaemia ≥ 100 mg/dl, HDL cholesterol <40 mg/dl, triglycerides ≥100 mg/dl (children <10 years) or ≥130 mg/dl (children ≥10 years). A multivariate logistic regression analysis was used to estimate the association between MUO phenotype and non-traditional cardiovascular risk factors. Results: The prevalence of the MUO status was high (61%). MUO subjects were more often male, older and pubertal (p < 0.001). The levels of the three non-traditional risk factors were significantly higher in MUO children compared to MHO children (p < 0.001) and all of them were independent predictors of the fact of being MUO [OR 1.41 (95% CI 1.24–1.69); 1.15 (95% CI 1.06–1.23) and 1.03 (95% CI1.01–1.05) for Uric Acid, HOMA index and W-Hr, respectively]. About 15% of MHO subjects had serum Uric Acid, HOMA index and W-Hr values within the highest quartile of the study population. Conclusion: The prevalence of MUO subjects in a large pediatric population is high and serum Uric Acid, HOMA index and W-Hr values are independent predictors of the prob

Published
2020

5. Determinants of the lifestyle changes during covid-19 pandemic in the residents of northern italy

Author

Cancello, R, Soranna, D, Zambra, G, Zambon, A, Invitti, C, Cancello R., Soranna D., Zambra G., Zambon A., Invitti C., Cancello, R, Soranna, D, Zambra, G, Zambon, A, Invitti, C, Cancello R., Soranna D., Zambra G., Zambon A., and Invitti C.

Abstract

Background: The confinement recommended during COVID-19 pandemic could affect behavior and health. Methods: We conducted a self-reported survey in northern Italy to observe the lockdown effects on lifestyle changes and to assess their determinants. Prevalence Odds Ratio and Prevalence Risk Ratio were determined. Results: 490 adults (84% female) completed the survey: 13% and 43% reported improved and unchanged sleep quality, respectively, while 43% had insomnia symptoms. Among the 272 active subjects in pre-lockdown, 14% continued habitual exercising, 18% increased it and 68% reduced it; 27% of sedentary subjects started physical exercise; 34% reported an improvement in diet quality; 42% increased food intake and 13% decreased it; and 38% of the smokers increased cigarette consumption. Age and the pre-lockdown habit of regular physical exercising were the mainly determinants of lifestyle changes whereas BMI, gender, and the presence of chronic diseases did not. Living with other people increased the likelihood of increasing the food intake (p= 0.002). Conclusions: More than a third of people were able to positively reorganize their lives during the forced home confinement. It is worth to disseminate information to preserve a healthy lifestyle even when confined at home.

Published
2020

7. Impaired fasting glucose and impaired glucose tolerance in children and adolescents with overweight/obesity

Author

Di Bonito, P., Pacifico, L., Chiesa, C., Valerio, G., Miraglia Del Giudice, E., Maffeis, C., Morandi, A., Invitti, C., Licenziati, M. R., Loche, S., Tornese, G., Franco, F., Manco, M., Baroni, M. G., Driul, D., Grandone, A., Incani, M., Pani, M. G., Tomat, Michela, Sanguigno, E., Gilardini, L., Pellegrin, M. C., Di Bonito, P., Pacifico, L., Chiesa, C., Valerio, G., Miraglia Del Giudice, E., Maffeis, C., Morandi, A., Invitti, C., Licenziati, M. R., Loche, S., Tornese, G., Franco, F., Manco, M., Baroni, M. G., Driul, D., Grandone, A., Incani, M., Pani, M. G., Tomat, Michela, Sanguigno, E., Gilardini, L., Pellegrin, M. C., Di Bonito, P, Pacifico, L, Chiesa, C, Valerio, G, Miraglia Del Giudice, E, Maffeis, C, Morandi, A, Invitti, C, Licenziati, M R, Loche, S, Tornese, G, Franco, F, Manco, M, and Baroni, M G

Subjects
Blood Glucose, Male, endocrine system diseases, Endocrinology, Diabetes and Metabolism, prediabetes, Overweight, Impaired glucose tolerance, 0302 clinical medicine, Endocrinology, impaired fasting glucose, Prevalence, Insulin, 030212 general & internal medicine, Prediabetes, Child, Glucose tolerance test, medicine.diagnostic_test, Cardiometabolic risk factors, Impaired fasting glucose, Pediatric obesity, Fasting, Diabetes and Metabolism, Italy, Prediabete, Adolescent, Case-Control Studies, Female, Glucose Intolerance, Glucose Tolerance Test, Humans, Insulin Resistance, Obesity, Prediabetic State, medicine.symptom, Case-Control Studie, hormones, hormone substitutes, and hormone antagonists, Human, medicine.medical_specialty, pediatric obesity, 030209 endocrinology & metabolism, 03 medical and health sciences, Insulin resistance, Internal medicine, medicine, Cardiometabolic risk factor, business.industry, Case-control study, nutritional and metabolic diseases, medicine.disease, cardiometabolic risk factors, impaired glucose tolerance, business
Abstract

OBJECTIVE: To investigate in a large sample of overweight/obese (OW/OB) children and adolescents the prevalence of prediabetic phenotypes such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), and to assess their association with cardiometabolic risk (CMR) factors including hepatic steatosis (HS). METHODS: Population data were obtained from the CARdiometabolic risk factors in children and adolescents in ITALY study. Between 2003 and 2013, 3088 youths (972 children and 2116 adolescents) received oral glucose tolerance test (OGTT) and were included in the study. In 798 individuals, abdominal ultrasound for identification of HS was available. RESULTS: The prevalence of IFG (3.2 vs. 3.3%) and IGT (4.6 vs. 5.0%) was similar between children and adolescents. Children with isolated IGT had a 2-11 fold increased risk of high LDL-C, non-HDL-C, Tg/HDL-C ratio, and low insulin sensitivity, when compared to those with normal glucose tolerance (NGT). No significant association of IFG with any CMR factor was found in children. Among adolescents, IGT subjects, and to a lesser extent those with IFG, showed a worse CMR profile compared to NGT subgroup. In the overall sample, IGT phenotype showed a twofold increased risk of HS compared to NGT subgroup. CONCLUSIONS: Our study shows an unexpected similar prevalence of IFG and IGT between children and adolescents with overweight/obesity. The IGT phenotype was associated with a worse CMR profile in both children and adolescents. Phenotyping prediabetes conditions by OGTT should be done as part of prediction and prevention of cardiometabolic diseases in OW/OB youth since early childhood.

Published
2016

8. A high protein diet is more effective in improving insulin resistance and glycemic variability compared to a mediterranean diet—a cross-over controlled inpatient dietary study

Author

Tettamanzi, F, Bagnardi, V, Louca, P, Nogal, A, Monti, G, Mambrini, S, Lucchetti, E, Maestrini, S, Mazza, S, Rodriguez-Mateos, A, Scacchi, M, Valdes, A, Invitti, C, Menni, C, Monti, GS, Mambrini, SP, Valdes, AM, Tettamanzi, F, Bagnardi, V, Louca, P, Nogal, A, Monti, G, Mambrini, S, Lucchetti, E, Maestrini, S, Mazza, S, Rodriguez-Mateos, A, Scacchi, M, Valdes, A, Invitti, C, Menni, C, Monti, GS, Mambrini, SP, and Valdes, AM

Abstract

The optimal dietary pattern to improve metabolic function remains elusive. In a 21-day randomized controlled inpatient crossover feeding trial of 20 insulin-resistant obese women, we assessed the extent to which two isocaloric dietary interventions—Mediterranean (M) and high protein (HP)—improved metabolic parameters. Obese women were assigned to one of the following dietary sequences: M–HP or HP–M. Cardiometabolic parameters, body weight, glucose monitoring and gut microbiome composition were assessed. Sixteen women completed the study. Compared to the M diet, the HP diet was more effective in (i) reducing insulin resistance (insulin: Beta (95% CI) = −6.98 (−12.30, −1.65) µIU/mL, p = 0.01; HOMA-IR: −1.78 (95% CI: −3.03, −0.52), p = 9 × 10−3 ); and (ii) improving glycemic variability (−3.13 (−4.60, −1.67) mg/dL, p = 4 × 10−4 ), a risk factor for T2D development. We then identified a panel of 10 microbial genera predictive of the difference in glycemic variability between the two diets. These include the genera Coprococcus and Lachnoclostridium, previously associated with glucose homeostasis and insulin resistance. Our results suggest that morbidly obese women with insulin resistance can achieve better control of insulin resistance and glycemic variability on a high HP diet compared to an M diet.

Published
2021

9. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Author

Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ, Novo S, Krum H, Varigos J, Siostrzonek P, Sinnaeve P, Gotcheva N, Yong H, Urina-Triana M, Milicic D, Vettus R, Manolis AJ, Wyss F, Sigurdsson A, Fucili A, Veze I, Petrauskiene B, Salvador L, Klemsdal TO, Medina F, Budaj A, Otasevic P, Lainscak M, Seung KB, Commerford P, Donath M, Hwang JJ, Kultursay H, Bilazarian S, East C, Forgosh L, Harris B, Ligueros M, Bohula E, Charmarthi B, Cheng S, Chou S, Danik J, McMahon G, Maron B, Ning M, Olenchock B, Pande R, Perlstein T, Pradhan A, Rost N, Singhal A, Taqueti V, Wei N, Burris H, Cioffi A, Dalseg AM, Ghosh N, Gralow J, Mayer T, Rugo H, Fowler V, Limaye AP, Cosgrove S, Levine D, Lopes R, Scott J, Hilkert R, Tamesby G, Mickel C, Manning B, Woelcke J, Tan M, Manfreda S, Ponce T, Kam J, Saini R, Banker K, Salko T, Nandy P, Tawfik R, O’Neil G, Manne S, Jirvankar P, Lal S, Nema D, Jose J, Collins R, Bailey K, Blumenthal R, Colhoun H, Gersh B, Abreu M, Actis MV, Aiub J, Aiub F, Albisu J, Alvarisqueta A, Avalos V, Barreto M, Berli MA, Blumberg C, Bocanera M, Botta C, Bowen L, Budassi N, Buhlman S, Westberg JC, Carabajal T, Caruso G, Casala J, Cendali G, Coloma G, Berra FC, Cuneo C, Degennaro N, Dellasa M, Diaz M, Dos Santos P, Espinosa V, Facello A, Facello M, Farias E, Fernandez AA, Ferrari V, Pacora FF, Flores GS, Franco M, Gabito A, Viola HG, Garcia F, Garcia Duran R, Garcia Pinna J, Glenny J, Godoy Sanchez M, Grosse A, Guzman P, Hasbani E, Hominal M, Ibañez J, Jure H, Jure D, Vico ML, Liniado G, Luciardi H, Luquez H, Maehara G, Maffei L, Majul C, Mallagray M, Marinaro S, Martinez J, Massaccesi R, De Los Milagros Had M, Azize GM, Montana O, Montenegro E, Morell Y, Muntaner J, Navarrete S, Olmedo M, Paganini M, Paz S, Perez Manghi F, Piskorz D, Polato C, Recoaro R, Romano A, Salinger M, Sanchez A, Saravia MA, Sarjanovich R, Scaro G, Schiavi LB, Soler J, Tinnirello V, Tomassi A, Valle M, Vallejo MA, Venturini C, Marcela Wenetz LM, Yossen M, Zaidman C, Zalazar L, Zangroniz P, Amerena J, Brady L, Colquhoun D, Eccleston D, Ferreira-Jardim A, French J, Jayasinghe R, Mcintosh C, Ord M, Plotz M, Purnell P, Roberts-Thomson P, Schultz C, Shanahan T, Tan R, Taverner P, Turner F, Vibert J, Vorster M, William M, Youssef G, Bergler-Klein J, Brath H, Brodmann M, Fliesser-Goerzer E, Haider K, Heeren G, Hiden C, Mandic L, Paulweber B, Ploechl A, Prenner A, Steringer-Mascherbauer R, Strohner-Kaestenbauer H, Barbato E, Bouvy C, Briké C, Charlier F, Cools F, De Knijf K, De Wolf L, Delforge M, Deweerdt N, Gits F, Goffinet C, Hermans K, Hollanders G, Mestdagh I, Pirenne B, Servaes V, Simons N, Tahon S, Theunissen E, Van Genechten G, Vervoort G, Vissers C, Vranckx P, Vrolix M, Abib E Jr, Abrantes J, Araujo Fonseca M, Barbosa E, Barroso W, Barroso A, Bodanese L, Botelho R, Costa Amorim R, Da Costa F, Da Silva A, Da Silva O Jr, Da Silva D Jr, Ferreira Dos Santos T, Dos Santos F, Dos Santos A, Duda N, Feitosa G, Felario Junior GA, Ferraz R, Filho P, Fonseca A, Wanderley FF, Freitas E, Fucci F, Marengo Garcia De Carvalho L, Hernandez M, Hettwer Magedanz E, Julião K, Kormann A, Lameira A, Lima F, Lino E, Maia L, Manenti E, Marchi AL, Fischer SM, Michalaros Y, Moraes J Jr, Moreira L, Pagnan M, Pesce F, Pinheiro L, Rassi S, Reis G, Reis H, Resende I, Roel A, Ruschel K, Saporito W, Saraiva JF, Seroqui M, Silva R, Unterkircher B, Vicente C, Vieira N, Xavier JP, Zucchetti C, Angelova I, Dimitrov G, Genova D, Gospodinov K, Goudev A, Grigorova V, Hristova K, Makedonska JJ, Katova T, Kostov K, Lazov P, Manov E, Manukov I, Manukov D, Milanova M, Kabakchieva VM, Petrov D, Petrusheva T, Pramatarova I, Raev D, Runev N, Sirakova-Taseva A, Tisheva-Gospodinova S, Todorova A, Tzekova M, Yakovova S, Yanev T, 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Lee J, Lee HN, Lee JH, Lee KR, Moon K, Park B, Park C, Tahk S, Yim KH, Yim S, Tase T, Andor M, Aron G, Badea C, Casoinic F, Clocotan M, Coman S, Emil B, Imre BS, Istratoaie O, Liviu C, Maximov D, Militaru C, Minescu B, Istvan KP, Parepa I, Petrescu L, Podoleanu C, Pop CF, Popa V, Popescu E, Radoi M, Sarbu I, Socoteanu E, Socoteanu G, Sorodoc L, Spiridon M, Stanciulescu G, Stefanescu M, Tanaseanu C, Tudoran M, Zdrenghea D, Agafina A, Akatova E, Avdonina N, Balukova E, Barbarash OL, Bartosh L, Boyarkin M, Bulashova O, Burova N, Churina S, Demidova M, Dorogova I, Dovgalevskiy Y, Dovgolis S, Dudarev M, Fitilev S, Gapon L, Gazizianova V, Gordeev I, Ivanov I, Izmozherova N, Kazanskay E, Khirmanov V, Khromtsova O, Konradi A, Kosmacheva E, Kozlova S, Kulibaba E, Kuzin A, Libov I, Lipchenko A, Lozhkina N, Malchikova S, Morozov E, Myslyaeva L, Onuchina E, Palatkina T, Panov A, Parmon E, Petelina T, Repin A, Reznik I, Sazonova E, Sergienko T, Shaposhnik I, Shapovalova Y, Shustov S, Shvarts Y, Skopets I, Skuratova M, Smolenskaya O, Solovev O, Trofimov V, Vasiliev M, Vezikova N, Vozzhaev A, Yakushin S, Zadionchenko V, Apostolovic S, Adjic NC, Ilic I, Ilic S, Nikolic L, Pupic L, Stokuca-Korac N, Antalik L, Bugan V, Csala L, Dokupilova A, Dzupina A, Forgon T, Fulop P, Gonsorcik J, Gyorgyova E, Holoubek D, Horvat P, Kamensky G, Kolikova V, Krupciakova B, Lenner E, Lennerova J, Lukac J, Majercak I, Mancikova I, Micko K, Nociar J, Pales J, Palka J Jr, Poliacik P, Ruffini L, Sabo L, Skubova K, Slanina M, Smik R, Srdos V, Stitova M, Stofkova D, Strbova J, Such S, Toth P, Urgeova L, Vinanska D, Zareczky P, Flezar M, Kovacic D, Marcun R, Zagozen P, Bolsmann C, Commerford P, Conradie C, Dawood SY, Decsi KL, Ebrahim I, Henley L, Horak A, Kapp I, Komati S, Lock E, Maboyi S, Makotoko E, Manga P, Page A, Ramdas S, Ranjith N, Roos J, Talliard C, Ajax K, Al-Khalili F, Assarsson E, Bergholtz T, Blom KB, Boman K, Boström PÅ, Curiac D, Jensen ED, Dahlen G, Davidsson K, Duckert A, Hansson A, Härstedt N, Henriksson A, Olsson GH, Johansson K, Jonsson JE, Knutsson A, Lindholm CJ, Liu B, Lönnberg I, Lundqvist M, Mellberg L, Moodh J, Mooe T, Olofsson M, Risenfors M, Rönndahl M, Sundelin R, Suorra I, Torgersruud M, Torstensson I, Chang KC, Chen CP, Chen ZC, Chen MH, Cheng SM, Cheng JJ, Fang CY, Ho CJ, Hsieh IC, Huang PH, Huang A, Hwang JJ, Kuo JY, Lai WT, Lee SC, Li YH, Lin T, Liu HM, Tsai MC, Tsao HM, Tzong L, Ueng KC, Wang YL, Wang HC, Wang CP, Yang CC, Abaci F, Birdane A, Yilmaz MB, Asim Oktay AO, Kan G, Koldas N, Ozcan IT, Sahin M, Sahin T, Saka B, Tekten T, Ucar N, Uresin S, Yigit Z, Arif I, Bakhai A, Baksi A, Blagdon M, Brickman T, Brown N, Burton M, Burton J, Chaggar S, Chung A, Collier D, Covell W, Crawford G, Davies N, Davies M, Dayer M, Doughty A, Duff J, Dwenger E, Fisher J, Fitzpatrick L, Garner K, Glover J, Haughton G, Ilsley M, Ivan P, Voyzey EJ, Keenan S, Kelt T, Knight J, Kondagunta V, Lang C, Lee K, Lim L, Macdonald J, Mathew A, Mckenzie A, Mckibbin A, Michalska A, Pagett K, Pogson A, Price R, Price D, Procter K, Pye M, Redfearn H, Rewbury J, Ryding A, Sattar N, Sharp A, Shaw P, Simpson H, Smith W, Squire I, Storey R, Teenan M, Thomas H, Townend J, Trevelyan J, Wakeling J, Walukiewicz P, Wilkinson S, Zaman A, Acevedo L, Benton J, Abbate A, Aboufakher R, Acampora M, Acampora D, Aceto L, Acevedo B, Acheatel R, Adams M, Adams A, Ahmad I, Ahmed SH, Aish B, Akyea-Djamson A, Al Joundi T, Alcide P, Alfieri A, Alfonso T, Alfrey A, Allen J, Alllison DC, Almaliky T, Amos A, Angiolillo D, Antolick A, Ara M, Aragorn L, Arevalo S, Armas E, Arthur A, Asafu-Adjaye N, Ashcom T, Ashford M, Aslam A, Ather N, Atieh M, Aull L, Ayala M, Azizad M, Backer T, Baehl S, Bailey S, Bair S, Baker C, Ballmajo M, Pieretti HB, Baquero A, Barnett S, Baron S, Bartkowiak A, Bashir K, Beall K, Beauregard LA, Sarah S, Beckett L, Belejchak P, Bendelow T, Bender D, Benjamin S, Berdoff R, Berger V, Bergeron P, Berk M, Bernstein M, Binns Y, Bitzer V, Blahey M, Bloch S, Bluemel J, Boffetti P, Boley K, Bonner J, Boudreaux R, Boulanger K, Bradley A, Bramlet D, Bredlau C, Briggs S, Brousalis L, Brown S, Brown C, Buchannan C, Burke W, Burley T, Burton C, Burtt D, Byars W, Caballero-Valiente B, Carr K, Halliwell TC, Castillo J, Cei L, Cerda L, Chambers J, Chamblee T, Chattin W, Chee L, Chen YC, Cherlin R, Cheung D, Chiodi L, Christensen L, Christenson S, Cislowski D, Clavier-Firmin C, Colfer H, Colvin T, Cosgrove N, Covert C, Cox B, Cox R, Craig W, Crandall L, Crepps K, Cromer M, Cruz H, Cruz H, Cruz M, Cucher F, Damron M, Dave K, Dave B, Davis M, Davis B, Dawkins-Hughes S, Dean J, Debnam S, Defosse C, Dehning M, Dela Llana A, Dellorso M, Denham D, Desalle D, Dettmer M, Dhawan M, Diago M, Dicken T, Diederich C, Diederich M, Diehl R, Digangi D, Diller P, Dimattia M, Dodds G, Doggett J, Donahue K, Doughty L, Dragutksy B, Dreese M, Dunhurst F, Dunn D, Dutka C, Earl J, Eaton C, Eaves W, Ebeling K, Eder F, Edgerton L, Edillo C, Edwards J, Edwards T, Einhorn D, El Hafi S, Ellis M, Erickson B, Ervin W, Eskridge L, Fail P, Falcon D, Fang C, Fattal P, Fawson A, Felix L, Ferdinand K, Fien E, Fintel D, Firek C, Fitz-Patrick D, Flores E, Flores E, Flores H, Floro T, Forker A, Foster M, Foucauld J, Lehman KF, Fox B, Francoeur L, Frandsen B, Frandsen B, Frivold G, Fruchter G, Fullerton D, Gabriel J, Gacioch G, Garas S, Garcia N, Garcia Rinaldi R, Garcia-Fragoso V, Garcia-Portela M, Gelb R, George F, Ghali J, Gilbert J, Gilley J, Glancy R, Goff R, Goldberg N, Gonzales D, Gonzales V, Gonzalez E, Gorges R, Gould R, Grabeau R, Grable M, Graham JA, Graif J, Green E, Greener R, Greenway F, Grieshaber V, Griffin S, Gros C, Gudipati RVC, Guillinta P, Gupta V, Gutmann J, Gwyn M, El Hachem M, Hage F, Hageman T, Haidar A, Hakas J, Haldis T, Hall L, Hall C, Hall S, Halpern S, Hamud-Socoro A, Hardee L, Harrell W, Harrington A, Hartwell J, Hasan F, Hattler B, Haught H, Haynes E, Haywood A, Heaney L, Hecht J, Hernandez I, Herzog W, Hess E, Hill H, Hilton T, Hinderaker P, Hodnett P, Hoffman M, Hogan C, Holmes Z, Rees DH, Hotchkiss D, Huang P, Humbert J, Hutchens E, Iachini K, Ibarra M, Igbokidi O, Ilahi T, Imbrognio M, Ipp E, Iteld B, Jacques G, Jafri A, Jafry B, Jardula M, Jefferson D, Jenkins R, Johnson E, Johnson J, Jones S, Kawahara M, Kelehan S, Kelly R, Kendall T, Kereiakes D, Khan M, Khan S, Kick J, Kimmel M, King T, King A, Kirkland S, Kissel S, Kitchens D, Klein P, Klugherz B, Korban E, Koren M, Korte M, Kostis J, Kotek L, Kozak M, Kreutter F, Kusnick B, Labovitz R, Lail J, Lamance J, Lamas G, Lambert J, Lambert C, Landzberg J, Langdon J, Lavoie W, Ledger G, Lee T, Lee K, Lehman R, Leimbach W, Lennard M, Lepor N, Lester F, Levin P, Levinson L, Lewis D, Lillo J, Link L, Long C, Longaker R, Lorch G, Lucksinger G, Lynd S, Rhudy JM, Madder R, Magness K, Maheshwari A, Alan A, Malek M, Maletz L, Malhotra V, Malhotra S, Mandviwala M, Mani CK, Manuel J, Marchelletta N, Marshall L, Marsters M, Martin L, Martinez E, Mavromatis K, Maynard R, Mays M, Mays B, Mbulaiteye A, Mcalister R, Mccoy C, Mccrary D Jr, Mccullough-O'Brien H, Mcdonald M, Mcgill J, Mcgrew F, Mckenzie C, Mclaurin B, Mclellan BA, Mcneil D, Mcneill R, Mehrle A, Melbie K, Melliza T, Messina T, Meyer R, Michel K, Mikdadi G, Miller C, Miller R, Miller A, Miller G, Miller W, Mitchell J, Moats DJR, Mody F, Moffat J, Molk B, Molter D, Monroe T, Montero H, Montgomery R, Mookherjee D, Moran J, Moriarty P, Morrison J, Morton D, Moshayedi P, Mosley J, Moustafa M, Munshi K, Murray A, Mustafa J, Nadar V, Naidu R, Nalley J, Navy S, Neil L, Neutel JM, Niblack P, Nicely V, Nicolai M, Nijmeh G, Nikas A, Nikyar A, Nixon S, Norman L, Noto G, Nour K, Nugent A, Ocman B, Odegard A, Olsen S, Ortiz-Carrasquillo R, Ossino N, Paez H, Palchick B, Paliwal Y, Pannell R, Parfait V, Partridge J, Patel B, Patel R, Patel M, Patel S, Paysor C, Pena A, Pereira S, Perez M, Perez A, Perkins H, Perry B, Peters P, Phillippi C, Phillips A, Phillips A, Piacente R, Pintado M, Pish R, Pitt W, Poling T, Pomposini D, Poock J, Potts J, Poudrier R, Prior J, Pritchard C, Purighalla R, Quddusi K, Quinones J, Quinton D, Radin M, Radojcsics B, Rajput B, Rama B, Ramos M, Rauch R, Raynes K, Reber AM, Reddy J, Reeves M, Reilly K, Renaud K, Resnick H, Reyes R, Richardson M, Riethof M, Riser J, Rodero M, Rodriguez Araya E, Roper L, Rozeman P, Ruder D, Runquist L, Sack G, Saint-Jacques H, Salfity M, Sall N, Sam K, Samal A, Sanchez D, Santiago J Jr, Savignano C, Saylor R, Scheffel M, Schifferdecker B, Schindler E, Schneider P, Schneider R, Schnitzler R, Schrager B, Schwartz A, Scott R, Seals A, Shah AV, Shah A, Shatsky K, Shayani S, Shealy N, Sheets L, Shelley J, Shepard P, Shetty S, Silver K, Simon M, Singh K, Singh N, Sizemore BC, Skatrud L, Slayton C, Slimak V, Sloane G, Smallwood B, Smith P, Smith M, Smith T, Smith G, Smith B, Smith W, Smith M, Smith J, Smith J, Soca Y, Sofley C, Sopko K, Sosa-Padilla M, Sotolongo R, Sprinkle B, Srivastava S, Starzec M, Steinhoff J, Stelly L, Stinson J, Stoddard M, Stoltz S, Stone B, Stover T, Strain J, Strugatsky S, Stys T, Suleman A, Sullivan P, Tamez W, Tandon N, Teltser M, Terry PS, Terry K, Tessmar C, Thekkoott D, Thomas D, Thomas DM, Thompson E, Thompson J, Thornton A, Tjaden T, Tobias C, Topper J, Tran A, Treasure C, Trenkamp P, Trevino M, Tsou L, Tuholske C, Uy W, Vahtel M, Vaid B, Valenzuela M, Vance A, Vandam J, Vanhecke T, Vanness WC III, Vargas R, Vaz S, Vazquez Tanus J, Veerina K, Vega J, Vento A, Vijay N, Voelker F, Vogt E, Vold D, Vora K, Wade RD, Wadell C, Waksman R, Walker K, Walker K, Wallace K, Warren M, Washam M, Watson B, Webel R, Wells T, West M, Whitaker J, White J, White C, White A, White A, Wilhoit G, Wilkins M, Willingham K, Wilson S, Wilson V, Wise J, Woodall S, Woods A, Wright J, Wu J, Xu ZJ, Yarows S, Young A, Younis L, Zarate J, Zebrack J, Zhang W, Zieve F, Zineldine A, Ridker, P. M., Everett, B. M., Thuren, T., Macfadyen, J. G., Chang, W. H., Ballantyne, C., FONSECA E PIRES, CARLOS EDUARDO, Nicolau, J., Koenig, W., Anker, S. D., Kastelein, J. J. P., Cornel, J. H., Pais, P., Pella, D., Genest, J., Cifkova, R., Lorenzatti, A., Forster, T., Kobalava, Z., Vida-Simiti, L., Flather, M., Shimokawa, H., Ogawa, H., Dellborg, M., Rossi, P. R. F., Troquay, R. P. T., Libby, P., Glynn R., J, CANTOS Trial, Group, Perrone, Filardi, P, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, and ACS - Atherosclerosis & ischemic syndromes

Subjects
0301 basic medicine, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, c-reactive protein, Randomized controlled trial, law, Cardiovascular Disease, middle aged, double-blind method, antibodies, Myocardial infarction, humans, Stroke, interleukin-1beta, biology, Antibodies, Monoclonal, drug, General Medicine, Lipid, Aged, anti-inflammatory agents, monoclonal, humanized, atherosclerosis, cardiovascular diseases, dose-response relationship, female, incidence, infections, lipids, male, myocardial infarction, neutropenia, secondary prevention, stroke, Anti-Inflammatory Agent, aged, Editorial, Atherosclerosi, Monoclonal, Human, medicine.drug, medicine.medical_specialty, Neutropenia, Antibodies, Monoclonal, Humanized, Infections, Placebo, antibodies, monoclonal, dose-response relationship, drug, infection, medicine (all), 03 medical and health sciences, Internal medicine, medicine, Dose-Response Relationship, Drug, business.industry, Antiinflammatory Therapy, Canakinumab, for Atherosclerotic Disease, C-reactive protein, medicine.disease, Surgery, Canakinumab, 030104 developmental biology, biology.protein, business
Abstract

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.)

Published
2017

19. Clinical Symposium

Author

Boscaro, M., Sonino, N., Mantero, F., Müller, O. A., Bertagna, X., Buchfelder, M., Fahlbusch, R., Scanarini, M., Zorat, P. L., Lora, O., Calzavara, F., Ambrosi, B., Bochicchio, D., Colombo, P., Sartorio, A., Conti, A., Faglia, G., Loli, P., Lamberts, S. W. J., Invitti, C., Pecori Giraldi, F., De Martin, M., Tagliaferri, A., and Cavagnini, F.

Published
1992
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22. The long-term impact of renin-angiotensin system (RAS) inhibition on cardiorenal outcomes (LIRICO): A randomized, controlled trial

Author

Saglimbene, V., Palmer, S. C., Ruospo, M., Natale, P., Maione, A., Nicolucci, A., Vecchio, M., Tognoni, G., Craig, J. C., Pellegrini, F., Lucisano, G., Hegbrant, J., Ariano, R., Lamacchia, O., Sasso, A., Morano, S., Filardi, T., De Cosmo, S., Pugliese, G., Procaccini, D. A., Gesualdo, L., Palasciano, G., Johnson, D. W., Tonelli, M., Strippoli, G. F. M., Cignarelli, M., Di Mauro, M. D., Tonolo, G., Adinolfi, L. E., Gigante, A., Carboni, L., Anichini, R., Marino, C., Querques, M., Manfrini, S., Cianciaruso, B., Grandaliano, Giuseppe, Prato, S. D., Giorgino, F., Perin, P. C., Malberti, F., Nardo, A., Invitti, C., Panettieri, I., Bono-mini, M., Sesti, G., Altomare, E., Giordano, R., Iacono, A., Lusenti, T., Jovane, C., Zavaroni, I., Vernaglione, L., Grosso, J., Stratta, P., Andriani, A., Montanaro, A., Ciaula, A. D., Triolo, G., Santoro, A., Spada, S., Benedetto, A. D., Borzi, V., Tortul, C., Schiavoni, M., Cavalera, C., Iannarelli, R., Mileti, G., Tardi, S., Di Rosa, S., Saglimbene, V, Palmer, Ruospo, S. C., Natale, M., Maione, P., Nicolucci, A., Vecchio, A., Tognoni, M., Craig, G, Pellegrini, J. C., Lucisano, F., Hegbrant, G., Ariano, J., Lamacchia, R., Sasso, O., Morano, A., Filardi, S., Cosmo, De, Pugliese, Pier Paolo, Procaccini, G., Gesualdo, D. A., Palasciano, L., Johnson, G., Tonelli, D. W., Strippoli, M., Cignarelli, G. F. M., Mauro, Di, Tonolo, M. D., G, Adinolfi, Le, Gigante, A., Carboni, L., Anichini, R., Marino, Concetta, Querques, M., Manfrini, Cianciaruso, S., Grandaliano, B., Prato, G., Giorgino, S. D., Perin, F., Malberti, P. C., Nardo, F., Invitti, A. n., Cavalera, C., Iannarelli, C., Mileti, R., Tardi, G., and Rosa, Di

Subjects
Male, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, albuminuria, clinical trial, diabetic nephropathy, end-stage renal disease, mortality, renin angiotensin system, urologic and male genital diseases, law.invention, Renin-Angiotensin System, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, Settore MED/14 - NEFROLOGIA, 030212 general & internal medicine, General Medicine, Middle Aged, Cardiovascular disease, female genital diseases and pregnancy complications, Treatment Outcome, Cardiovascular Diseases, Nephrology, Hypertension, Drug Therapy, Combination, Female, medicine.symptom, medicine.drug, medicine.medical_specialty, Combination therapy, End stage renal disease, Angiotensin Receptor Antagonists, 03 medical and health sciences, Clinical Research, Internal medicine, Diabetes Mellitus, medicine, Albuminuria, Humans, Adverse effect, Aged, business.industry, Discontinuation, Clinical trial, ACE inhibitor, business, chronic kidney disease
Abstract

Background The comparative effectiveness of treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or their combination in people with albuminuria and cardiovascular risk factors is unclear. Methods In a multicenter, randomized, open label, blinded end point trial, we evaluated the effectiveness on cardiovascular events of ACE or ARB monotherapy or combination therapy, targeting BP,130/80 in patients with moderate or severe albuminuria and diabetes or other cardiovascular risk factors. End points included a primary composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for cardiovascular causes and a revised end point of all-cause mortality. Additional end points included ESRD, doubling of serum creatinine, albuminuria, eGFR, BP, and adverse events. Results Because of slow enrollment, the trial was modified and stopped 41% short of targeted enrollment of 2100 participants, corresponding to 35% power to detect a 25% reduced risk in the primary outcome. Our analysis included 1243 adults, with median follow-up of 2.7 years. Efficacy outcomes were similar between groups (ACE inhibitor versus ARB, ACE inhibitor versus combination, ARB versus combination) as were rates of serious adverse events. The rate of permanent discontinuation for ARB monotherapy (6.3%) was significantly lower than for ACE inhibitor monotherapy (15.7%) or combined therapy (18.3%). Conclusions Patients may tolerate ARB monotherapy better than ACE inhibitor monotherapy. However, data from this trial and similar trials, although as yet inconclusive, show no trend suggesting differences in mortality and renal outcomes with ACE inhibitors or ARBs as dual or monotherapy in patients with albuminuria and diabetes or other cardiovascular risk factors. Copyright © 2018 by the American Society of Nephrology Background The comparative effectiveness of treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or their combination in people with albuminuria and cardiovascular risk factors is unclear. Methods In a multicenter, randomized, open label, blinded end point trial, we evaluated the effectiveness on cardiovascular events of ACE or ARB monotherapy or combination therapy, targeting BP,130/80 in patients with moderate or severe albuminuria and diabetes or other cardiovascular risk factors. End points included a primary composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for cardiovascular causes and a revised end point of all-cause mortality. Additional end points included ESRD, doubling of serum creatinine, albuminuria, eGFR, BP, and adverse events. Results Because of slow enrollment, the trial was modified and stopped 41% short of targeted enrollment of 2100 participants, corresponding to 35% power to detect a 25% reduced risk in the primary outcome. Our analysis included 1243 adults, with median follow-up of 2.7 years. Efficacy outcomes were similar between groups (ACE inhibitor versus ARB, ACE inhibitor versus combination, ARB versus combination) as were rates of serious adverse events. The rate of permanent discontinuation for ARB monotherapy (6.3%) was significantly lower than for ACE inhibitor monotherapy (15.7%) or combined therapy (18.3%). Conclusions Patients may tolerate ARB monotherapy better than ACE inhibitor monotherapy. However, data from this trial and similar trials, although as yet inconclusive, show no trend suggesting differences in mortality and renal outcomes with ACE inhibitors or ARBs as dual or monotherapy in patients with albuminuria and diabetes or other cardiovascular risk factors.

Published
2018

23. Analysis of predictive equations for estimating resting energy expenditure in a large cohort of morbidly obese patients

Author

Cancello, R, Soranna, D, Brunani, A, Scacchi, M, Tagliaferri, A, Mai, S, Marzullo, P, Zambon, A, Invitti, C, Cancello, Raffaella, Soranna, Davide, Brunani, Amelia, Scacchi, Massimo, Tagliaferri, Antonella, Mai, Stefania, Marzullo, Paolo, Zambon, Antonella, Invitti, Cecilia, Cancello, R, Soranna, D, Brunani, A, Scacchi, M, Tagliaferri, A, Mai, S, Marzullo, P, Zambon, A, Invitti, C, Cancello, Raffaella, Soranna, Davide, Brunani, Amelia, Scacchi, Massimo, Tagliaferri, Antonella, Mai, Stefania, Marzullo, Paolo, Zambon, Antonella, and Invitti, Cecilia

Abstract

The treatment of obesity requires creating an energy deficit through caloric restriction and physical activity. Energy needs are estimated assessing the resting energy expenditure (REE) that in the clinical practice is estimated using predictive equations. In the present cross sectional study, we compared, in a large cohort of morbidly obese patients, the accuracy of REE predictive equations recommended by current obesity guidelines [Harris-Benedict, WHO/FAO/ONU and Mifflin-St Jeor (MJ)] and/or developed for obese patients (Muller, Muller BC, Lazzer, Lazzer BC), focusing on the effect of comorbidities on the accuracy of the equations. Data on REE measured by indirect calorimetry and body composition were collected in 4,247 obese patients (69% women, mean age 48 ± 19 years, mean BMI 44 ± 7 Kg/m2) admitted to the Istituto Auxologico Italiano from 1999 to 2014. The performance of the equations was assessed in the whole cohort, in 4 groups with 0, 1, 2, or =≥3 comorbidities and in a subgroup of 1,598 patients with 1 comorbidity (47.1% hypertension, 16.7% psychiatric disorders, 13.3% binge eating disorders, 6.1% endocrine disorders, 6.4% type 2 diabetes, 3.5% sleep apnoea, 3.1% dyslipidemia, 2.5% coronary disease). In the whole cohort of obese patients, as well as in each stratum of comorbidity number, the MJ equation had the highest performance for agreement measures and bias. The MJ equation had the best performance in obese patients with ≥3 comorbidities (accuracy of 61.1%, bias of -89.87) and in patients with type 2 diabetes and sleep apnoea (accuracy/bias 69%/-19.17 and 66%/-21.67 respectively), who also have the highest levels of measured REE. In conclusion, MJ equation should be preferred to other equations to estimate the energy needs of Caucasian morbidly obese patients when measurement of the REE cannot be performed. As even MJ equation does not precisely predict REE, it should be better to plan the diet intervention by measuring rather than estimating REE. Fut

Published
2018

24. Predictors of the transition from metabolically healthy obesity to unhealthy obesity

Author

Gilardini, L, Zambon, A, Soranna, D, Croci, M, Invitti, C, Gilardini, L, Zambon, A, Soranna, D, Croci, M, and Invitti, C

Abstract

Purpose: Evidence that metabolically healthy obesity (MHO) is a stable benign condition is unclear. The aim of this study was to estimate the transition of MHO subjects to unhealthy obesity (occurrence of cardio-metabolic events and/or risk factors) and its predictors. Methods: We conducted an explorative follow-up study in a subset of MHO patients > 40 years without any cardio-metabolic risk factors and with normal LDL cholesterol (LDLc) levels, identified among 1530 obese patients. Due to the low sample size, a bootstrap approach was applied to identify the variables to be included in the final multivariate discrete-time logit model. Results: The prevalence of MHO was 3.7%. During the follow-up (mean 6.1 years, SD 2.0), none of the MHO reported cardiovascular events, diabetes or prediabetes; 26 subjects developed risk factors (53% high LDLc and 50% hypertension). At the 6 and 12-year of follow-up, the cumulative incidence of transition to unhealthy obesity was 44% (95% CI 31–59%) and 62% (95% CI 45–79%), the incidence of high LDLc was 23% (95% CI 13–37%) and 40% (95% CI 25–59%) and that of hypertension was 20% (95% CI 11–33%) and 30% (95% CI 17–48%). LDLc and duration of follow-up were independent predictors of the transition from MHO to unhealthy obesity [OR 1.038 (1.005–1.072) and 1.360 (1.115–1.659)]. Conclusions: Results suggest that (a) MHO individuals do not move over time forward diabetes/prediabetes but develop risk factors, such as hypertension and higher LDL c that worsen the cardiovascular prognosis; (b) LDLc and the flow of time independently predict the transition to unhealthy status. Level of evidence: Level III, cohort study.

Published
2018

25. White blood cell count may identify abnormal cardiometabolic phenotype and preclinical organ damage in overweight/obese children

Author

Di Bonito, P., Pacifico, L., Chiesa, C., Invitti, C., Miraglia Del Giudice, E., Baroni, M. G., Moio, N., Pellegrin, M. C., Tomat, M., Licenziati, M. R., Manco, M., Maffeis, C., Valerio, G., Gilardini, L., Sanguigno, E., Driul, D., Grandone, A., Incani, M., Morandi, A., Tornese, G., Di Bonito, P., Pacifico, L., Chiesa, C., Invitti, C., Miraglia Del Giudice, E., Baroni, M. G., Moio, N., Pellegrin, M. C., Tomat, M., Licenziati, M. R., Manco, Maria, Maffeis, C., Valerio, G., Gilardini, L., Sanguigno, E., Driul, D., Grandone, A., Incani, M., Morandi, A., Tornese, G., and Manco, M.

Subjects
Blood Glucose, Male, Pediatric Obesity, Endocrinology, Diabetes and Metabolism, Left, Medicine (miscellaneous), Predictive Value of Test, 030204 cardiovascular system & hematology, Overweight, Carotid Intima-Media Thickness, Ventricular Function, Left, Leukocyte Count, 0302 clinical medicine, Endocrinology, Retrospective Studie, Risk Factors, Cardiovascular Disease, Nutrition and Dietetic, Prevalence, Medicine, Preclinical signs of organ damage, Ventricular Function, Age Factor, Child, Waist-to-height ratio, Metabolic Syndrome, Nutrition and Dietetics, Cardiometabolic risk factors, Overweight/obese children, White blood cell count, Diabetes and Metabolism, Cardiology and Cardiovascular Medicine, biology, Ventricular Remodeling, Liver Disease, Metabolic Syndrome X, Liver Diseases, Age Factors, Alanine Transaminase, Phenotype, Italy, Cardiovascular Diseases, Cardiology, Homeostatic model assessment, Female, medicine.symptom, Human, medicine.medical_specialty, Adolescent, 030209 endocrinology & metabolism, 03 medical and health sciences, Insulin resistance, Predictive Value of Tests, Carotid Intima-Media Thickne, Internal medicine, Humans, Biomarkers, Cross-Sectional Studies, Retrospective Studies, Cross-Sectional Studie, Cardiometabolic risk factor, business.industry, Risk Factor, Biomarker, medicine.disease, Obesity, Alanine transaminase, biology.protein, Metabolic syndrome, business, Body mass index
Abstract

Background and Aims Subclinical inflammation is a central component of cardiometabolic disease risk in obese subjects. The aim of the study was to evaluate whether the white blood cell count (WBCc) may help to identify an abnormal cardiometabolic phenotype in overweight (Ow) or obese (Ob) children. Methods and Results A cross-sectional sample of 2835 Ow/Ob children and adolescents (age 6–18 years) was recruited from 10 Italian centers for the care of obesity. Anthropometric and biochemical variables were assessed in the overall sample. Waist to height ratio (WhtR), alanine aminotransferase (ALT), lipids, 2 h post-load plasma glucose (2hPG), left ventricular (LV) geometry and carotid intima-media thickness (cIMT) were assessed in 2128, 2300, 1834, 535 and 315 children, respectively. Insulin resistance and whole body insulin sensitivity index (WBISI) were analyzed using homeostatic model assessment (HOMA-IR) and Matsuda's test. Groups divided in quartiles of WBCc significantly differed for body mass index, WhtR, 2hPG, HOMA-IR, WBISI, lipids, ALT, cIMT, LV mass and relative wall thickness. Children with high WBCc (≥8700 cell/mm 3 ) showed a 1.3–2.5 fold increased probability of having high normal 2hPG, high ALT, high cIMT, or LV remodeling/concentric LV hypertrophy, after adjustment for age, gender, pubertal status, BMI and centers. Conclusions This study shows that WBCc is associated with early derangements of glucose metabolism and preclinical signs of liver, vascular and cardiac damage. The WBCc may be an effective and low-cost tool for identifying Ow and Ob children at the greatest risk of potential complications.

Published
2015

26. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management

Author

Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C. W., le Roux, Carel W., Ortiz, Violante, Jensen, Christine Bjorn, Wilding, John P. H., Hamann, A, Barakat, A, Blüher, M, Linn, T, DALLE MOLLE, Alberto, Segner, A, Stübler, P, Tosch-Sisting, R, Pacini, F, Santini, F, Marchesini, G, Rotella, Cm, Invitti, C, Vettor, R, Buscemi, S, Raya, Pm, Freijoo, Fc, de Barbará RG, Carraro, R, Bobillo, Er, de la Cuesta, C, Farsang, C, Csaszar, A, Zahorska-Markiewicz, B, Pupek-Musialik, D, Franek, E, Ostrowska, L, Olszanecka-Glinianowicz, M, Lalic, N, Micic, D, Ludvik, B, Paulweber, B, Prager, R, Scheen, A, Van Gaal, L, Astrup, Av, Hermansen, K, Madsbad, S, Rissanen, A, Nieminen, S, Savolainen, M, Krempf, M, Romon, M, Laville, M, Marre, M, Mira, R, Finucane, F, Veenendaal, A, van Berkum, F, Johannsson-Vidarsdóttir, S, Van de Walle, V, Meesters, E, Hjelmesæth, J, Klemsdal, To, Kulseng, B, Bach-Kliegel, B, Laederach, K, Villiger, L, Golay, A, Bilz, S, Sathyapalan, T, Bain, S, Kumar, S, Le Roux CW, Lean, Me, Mcgowan, B, Rehman, T, Wilding, J, Wittert, G, Caterson, I, Proietto, J, Prins, J, Geloneze Neto, B, Gross, Jl, Chacra, Ar, Halpern, A, Suplicy Hde, A, Chow, Fc, Thacker, Hp, Chadha, M, Chandalia, H, Unnikrishnan, A, Kalra, S, Deshpande, N, Shunmugavelu, M, Deshmukh, Vc, Maislos, M, Lieberman, Gs, Shimon, I, Stern, N, Nabriski, D, Karnieli, E, Shehadeh, N, Gonzalez-Galvez, G, Arechavaleta-Granell Mdel, R, Violante Ortiz RM, Franco, Gm, Gurieva, I, Suplotova, La, Troshina, E, Ruyatkina, La, Voychik, Ea, Martsevich, S, Startseva, Ma, Seeber, Me, Badat, A, Ellis, G, Altuntas, Y, Guler, S, Ulgen, E, Delibasi, T, Chetty, T, Hart, R, Janzen, J, Labonte, I, Lau, D, Liutkus, J, O'Keefe, D, Padwal, R, Ransom, Tp, Tytus, R, Weisnagel, Sj, Adler, J, Aqua, K, Aronoff, Sl, Bedel, Gw, Blevins, Tc, Blumenau, J, Brockmyre, Ap, Call, Rs, Canadas, R, Chaykin, Lb, Cohen, K, Conrow, Jk, Davis, Mg, Downey, Hj, Drosman, Sr, Duckor, S, Farmer, H, Farrell, J, Fehnel, S, Finneran, Mp, Forbes, R, Forker, A, Fredrick, M, Fujioka, K, Geller, Sa, Gill, S, Glaser, L, Greco, Sn, Greenway, Fl, Harper, W, Herman, L, Hoekstra, J, Ingebretsen, R, Ison, R, Jain, Rk, Kaplan, R, Kaster, Sr, Haase, Ga, Kerzner, B, Kirstein, Jl, Koltun, W, Krieger, Dr, Lewis, Ce, Madder, R, Marple, Rn, Mcdermott, Ej, Mello, Cj, Miller, Ab, Mullen, J, Nardandrea, J, O'Neil, P, Pi-Sunyer, F, Pucillo, Rm, Rhee, C, Redrick, S, Pardini, A, Rothman, J, Rubino, Dm, Sellers, G, Smith, T, Byars, Wd, Soufer, J, Sussman, Am, Patrick, K, Schramm, El, Van Cleeff, M, Berg, Sr, Wyatt, Hr, Simon, Ja., Columbia University [New York], Obesity Research Center, The University of Tennessee [Knoxville], Department of Nutrition, Exercise and Sports [Copenhagen], Faculty of Science [Copenhagen], University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU), Scripps Research Institute, Louisiana State University (LSU), Universidade de São Paulo (USP), Centre hospitalier universitaire de Nantes (CHU Nantes), University of Calgary, University College Dublin (UCD), Instituto Mexicano del Seguro Social [Mexico City, Mexico] (IMSS), Novo Nordisk, Department of Obesity and Endocrinology, University of Liverpool, Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C.W., Le Roux, Carel W., Ortiz, Rafael Violante, Jensen, Christine Bjørn, Wilding, John P.H., the SCALE Obesity and Prediabetes NN8022-1839 Study Group [.., Marchesini, Giulio, ], Pi-Sunyer, X., Astrup, A., Fujioka, K., Greenway, F., Halpern, A., Krempf, M., Lau, D., le Roux, C., Violante Ortiz, R., Jensen, C., Wilding, J. COLLABORATORS: amann A, Barakat A, Blüher M, Linn T, Mölle A, Segner A, Stübler P, Tosch-Sisting R, Pacini F, Santini F, Marchesini G, Rotella CM, Invitti C, Vettor R, Buscemi S, and Raya PM, Freijoo FC, de Barbará RG, Carraro R, Bobillo ER, de la Cuesta C, Farsang C, Csaszar A, Zahorska-Markiewicz B, Pupek-Musialik D, Franek E, Ostrowska L, Olszanecka-Glinianowicz M, Lalic N, Micic D, Ludvik B, Paulweber B, Prager R, Scheen A, Van Gaal L, Astrup AV, Hermansen K, Madsbad S, Rissanen A, Nieminen S, Savolainen M, Krempf M, Romon M, Laville M, Marre M, Mira R, Finucane F, Veenendaal A, van Berkum F, Johannsson-Vidarsdóttir S, Van de Walle V, Meesters E, Hjelmesæth J, Klemsdal TO, Kulseng B, Bach-Kliegel B, Laederach K, Villiger L, Golay A, Bilz S, Sathyapalan T, Bain S, Kumar S, Le Roux CW, Lean ME, McGowan B, Rehman T, Wilding J, Wittert G, Caterson I, Proietto J, Prins J, Geloneze Neto B, Gross JL, Chacra AR, Halpern A, Suplicy Hde A, Chow FC, Thacker HP, Chadha M, Chandalia H, Unnikrishnan A, Kalra S, Deshpande N, Shunmugavelu M, Deshmukh VC, Maislos M, Lieberman GS, Shimon I, Stern N, Nabriski D, Karnieli E, Shehadeh N, Gonzalez-Galvez G, Arechavaleta-Granell Mdel R, Violante Ortiz RM, Franco GM, Gurieva I, Suplotova LA, Troshina E, Ruyatkina LA, Voychik EA, Martsevich S, Startseva MA, Seeber ME, Badat A, Ellis G, Altuntas Y, Guler S, Ulgen E, Delibasi T, Chetty T, Hart R, Janzen J, Labonte I, Lau D, Liutkus J, O'Keefe D, Padwal R, Ransom TP, Tytus R, Weisnagel SJ, Adler J, Aqua K, Aronoff SL, Bedel GW, Blevins TC, Blumenau J, Brockmyre AP, Call RS, Canadas R, Chaykin LB, Cohen K, Conrow JK, Davis MG, Downey HJ, Drosman SR, Duckor S, Farmer H, Farrell J, Fehnel S, Finneran MP, Forbes R, Forker A, Fredrick M, Fujioka K, Geller SA, Gill S, Glaser L, Greco SN, Greenway FL, Harper W, Herman L, Hoekstra J, Ingebretsen R, Ison R, Jain RK, Kaplan R, Kaster SR, Haase GA, Kerzner B, Kirstein JL, Koltun W, Krieger DR, Lewis CE, Madder R, Marple RN, McDermott EJ, Mello CJ, Miller AB, Mullen J, Nardandrea J, O'Neil P, Pi-Sunyer F, Pucillo RM, Rhee C, Redrick S, Pardini A, Rothman J, Rubino DM, Sellers G, Smith T, Byars WD, Soufer J, Sussman AM, Patrick K, Schramm EL, Van Cleeff M, Berg SR, Wyatt HR, Simon JA.

Subjects
Blood Glucose, Counseling, Male, Type 2 diabetes, law.invention, Body Mass Index, Randomized controlled trial, Weight loss, law, Glucagon-Like Peptide 1, Weight management, Subcutaneous, Medicine (all), Reducing, Nausea, General Medicine, Middle Aged, Combined Modality Therapy, 3. Good health, Female, type 2 diabetes, medicine.symptom, Human, medicine.drug, Adult, Diarrhea, medicine.medical_specialty, Diet, Reducing, Injections, Subcutaneous, Injections, Subcutaneou, Placebo, Injections, Double-Blind Method, Internal medicine, Weight Loss, medicine, Humans, Hypoglycemic Agents, Obesity, Exercise, Hypoglycemic Agent, Liraglutide, business.industry, medicine.disease, Weight Lo, Diet, Endocrinology, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Body mass index, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Dyslipidemia
Abstract

BACKGROUND: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS: At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P

Published
2015

29. The METABOLIC Study: Multidimensional assessment of health and functional status in older patients with type 2 diabetes taking oral antidiabetic treatment

Author

Maggi, S., Noale, M., Pilotto, A., Tiengo, A., Cavallo Perin, P., Crepaldi, G., Metabolic Working Group Collaborators:, Andrea C., Aglioloro, A., Allochis, G., Arico, C. N., Balbo, M., Marangoni, A., Balzano, S., Battisti, B., Testa, I., Brandoni, G., Bruno, A., Degiovanni, M., Buzzetti, Raffaella, Foffi, C., Calatola, P., Cantarella, S. A., Rondena, M., Cimpanelli, M. G., Confortin, L., Consoli, A., Baldassarre, M., Invitti, C., Conti, A., Del Prato, S., Crisci, I., Derosa, G., Maffioli, P., Devangelio, E., Di Bartolo, P., Ruggeri, P., Di Lembo, S., Di Mauro, M., Battiato, R., Farci, F., Fisicaro, M., Pontiroli, A., Folini, L., Gargiulo, A., Vinciguerra, A., Giorgino, F., Laviola, L., Clementina, C., Guerini, S., Tonolo, G., Iwaniszyn, D., Lambiase, C., Leotta, S., Mangeri, F., Mangili, R., Mattiuzzo, C., Mollo, F., Novara, F., Gucciardi, P., Orsi, E., Palmieri, E., Pacifico, A. A., Burruni, A., Pagani, G., Albizzi, M., Pasquini, C., Cavallo, P. P., Perotto, M., Piccolo, P., D'Ambrosio, P., Maolo, G., Polenta, B., Purrello, F., Tomaselli, T., Tardio, M. S., Quarantelli, C., Ragusa, G. S., Borzi, V., Rapisardi, R., Richini, D., Rosco, M., Serra, R., Marchesini, R. G., Soverini, V., Tomasi, F., De Angelis, M., Turco, A., Tolaini, P., Vangucci, S., and Zavaroni, I.

Subjects
Male, Drug, medicine.medical_specialty, Activities of daily living, Health Status, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, media_common.quotation_subject, Administration, Oral, Type 2 diabetes, Cohort Studies, Diabetes Complications, Endocrinology, Surveys and Questionnaires, Internal medicine, Diabetes mellitus, Internal Medicine, Humans, Hypoglycemic Agents, Medicine, Metabolic study, Aged, media_common, Aged, 80 and over, business.industry, Insulin, Age Factors, General Medicine, medicine.disease, Hypoglycemia, Malnutrition, Diabetes Mellitus, Type 2, Physical therapy, Female, business, Cohort study
Abstract

Aim The objective of the METABOLIC Study was to evaluate overall health status, with particular focus on assessment of functional status of older patients taking oral antidiabetic drug (OAD) treatment. Methods The study included 1342 type 2 diabetes patients aged ≥ 65 years treated with OADs, with or without insulin, who had been referred to outpatients clinics across Italy. Information on diabetes (duration, medications taken during the last 3 months, hypoglycaemic events and diabetic complications) was collected by questionnaire, and the patients’ overall health status was assessed using a multidimensional prognostic index. Results The sample recruited (mean age: 73.3 ± 5.5 years) had a mean duration of diabetes of 11.3 ± 8.2 years. Half were taking sulphonylureas alone or together with other medications, 9.7% were taking insulin in combination with other OADs, almost 30% were using biguanides and 6.2% were taking dipeptidyl peptidase-4 (DPP-4) inhibitors. Also, 12% of patients reported hypoglycaemic events, 90% of whom were taking insulin or sulphonylureas. In addition, 81% of the participants were completely independent in their activities of daily living, while 19% were mildly, moderately or severely disabled. Age, female gender, hypoglycaemic events, neuropathy and low diastolic blood pressure were the main variables associated with disability. Conclusion Disability is common in older diabetic patients and some associated factors, such as hypoglycaemia and low diastolic blood pressure, have been identified. Also identified was malnutrition as a specific factor associated with hypoglycaemic events independent of the use of insulin and sulphonylureas.

Published
2013

32. Glucose tolerance and weight loss in obese women with obstructive sleep apnea

Author

Gilardini, L, Lombardi, C, Redaelli, G, Vallone, L, Faini, A, Mattaliano, P, Parati, G, Invitti, C, GILARDINI, LUISA, LOMBARDI, CAROLINA, FAINI, ANDREA, MATTALIANO, PAOLA, PARATI, GIANFRANCO, Invitti, C., Gilardini, L, Lombardi, C, Redaelli, G, Vallone, L, Faini, A, Mattaliano, P, Parati, G, Invitti, C, GILARDINI, LUISA, LOMBARDI, CAROLINA, FAINI, ANDREA, MATTALIANO, PAOLA, PARATI, GIANFRANCO, and Invitti, C.

Abstract

Background: The association of obstructive sleep apnea (OSA) with glucose intolerance and the beneficial effect of lifestyle intervention have been poorly investigated in women particularly before menopausal status. The study explored 1) whether OSA is associated with impaired glucose homeostasis in obese non diabetic premenopausal and menopausal women and 2) the effects of a 3- month lifestyle intervention on glucose homeostasis in OSA women. Design and Methods: We consecutively recruited 98 obese women (39 premenopausal) from those referred for a weight loss intervention. Ambulatory nocturnal polysomnography, body composition, oral glucose tolerance test, insulin sensitivity and b cell function were assessed before and after intervention. Results: 41% of premenopausal and 64% of menopausal women had OSA which was associated with worse glucose homeostasis before menopausal status. Mean and minimal nocturnal oxygen saturation (SaO2) was associated with neck/height ratio (NHR), independently of total and central obesity. Mean and minimal nocturnal SaO2 and NHR were correlated with insulin sensitivity and fasting glucose. In multivariate analyses, nocturnal mean SaO2 was negatively and independently correlated with fasting glucose (p,0.0001) and NHR with insulin sensitivity (p,0.0001). In OSA women, the intervention induced a 5% weight reduction and a significant increase in minimal nocturnal SaO2, insulin sensitivity and b cell function. Changes in fasting glucose and insulin sensitivity were associated with those in minimal nocturnal SaO2 (p,0.05) and not with weight loss. Conclusions: In obese women, glucose homeostasis worsens due to nocturnal hypoxia and increased neck circumference through mechanisms partially independent of obesity. OSA is more clearly associated with glucose intolerance in premenopausal than in menopausal women. In OSA women, the improvement of nocturnal hypoxia induced by lifestyle modifications is associated with that of glucose homeostasis

Published
2013

33. A new index to simplify the screening of hypertension in overweight or obese youth

Author

Di Bonito, P., primary, Valerio, G., additional, Pacifico, L., additional, Chiesa, C., additional, Invitti, C., additional, Morandi, A., additional, Maffeis, C., additional, Licenziati, M.R., additional, Manco, M., additional, Miraglia del Giudice, E., additional, Baroni, M.G., additional, Loche, S., additional, Tornese, G., additional, Tomat, M., additional, de Simone, G., additional, Gilardini, L., additional, Sanguigno, E., additional, Franco, F., additional, Grandone, A., additional, Luciano, R., additional, Incani, M., additional, and Pellegrin, M.C., additional

Published
2017
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36. 2016 European Society ofHypertension guidelines for themanagement of high blood pressure in children and adolescents

Author

Lurbe, E, Agabiti-Rosei, E, Cruickshank, J, Dominiczak, A, Erdine, S, Hirth, A, Invitti, C, Litwin, M, Mancia, G, Pall, D, Rascher, W, Redon, J, Schaefer, F, Seeman, T, Sinha, M, Stabouli, S, Webb, N, Wühl, E, Zanchetti, A, Cruickshank, JK, Webb, NJ, Lurbe, E, Agabiti-Rosei, E, Cruickshank, J, Dominiczak, A, Erdine, S, Hirth, A, Invitti, C, Litwin, M, Mancia, G, Pall, D, Rascher, W, Redon, J, Schaefer, F, Seeman, T, Sinha, M, Stabouli, S, Webb, N, Wühl, E, Zanchetti, A, Cruickshank, JK, and Webb, NJ

Abstract

Increasing prevalence of hypertension (HTN) in children and adolescents has become a significant public health issue driving a considerable amount of research. Aspects discussed in this document include advances in the definition of HTN in 16 year or older, clinical significance of isolated systolic HTN in youth, the importance of out of office and central blood pressure measurement, new risk factors for HTN, methods to assess vascular phenotypes, clustering of cardiovascular risk factors and treatment strategies among others. The recommendations of the present document synthesize a considerable amount of scientific data and clinical experience and represent the best clinical wisdom upon which physicians, nurses and families should base their decisions. In addition, as they call attention to the burden of HTN in children and adolescents, and its contribution to the current epidemic of cardiovascular disease, these guidelines should encourage public policy makers to develop a global effort to improve identification and treatment of high blood pressure among children and adolescents.

Published
2016

37. White blood cell count may identify abnormal cardiometabolic phenotype and preclinical organ damage in overweight/obese children

Author

Di Bonito, P., primary, Pacifico, L., additional, Chiesa, C., additional, Invitti, C., additional, Miraglia Del Giudice, E., additional, Baroni, M.G., additional, Moio, N., additional, Pellegrin, M.C., additional, Tomat, M., additional, Licenziati, M.R., additional, Manco, M., additional, Maffeis, C., additional, and Valerio, G., additional

Published
2016
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39. Molecular and morphologic characterization of superficial- and deep-subcutaneous adipose tissue subdivisions in human obesity

Author

Cancello, R, Zulian, A, Gentilini, D, Maestrini, S, Della Barba, A, Invitti, C, Cora', Davide, Caselle, Michele, Liuzzi, A, and Di Blasio, A. M.

Subjects
Adult, Adipocytes, Subcutaneous Fat, Gene Expression, Humans, Cell Differentiation, Female, Adiponectin, Obesity, Intra-Abdominal Fat, Middle Aged, Microarray Analysis, Subcutaneous Fat, Abdominal
Abstract

Human abdominal subcutaneous white adipose tissue (SAT) is composed of two different subcompartments: a "superficial" SAT (SSAT), located between the skin and a fibrous-fascia plane; and a deeper SAT, located under this fibrous fascia plane, indicated as "deep" SAT (DSAT).In order to investigate whether SSAT and DSAT have different molecular and morphological features, paired SSAT/DSAT biopsies were collected from 10 female obese patients and used for microarray and morphologic analysis. The stroma-vascular fraction cells were also isolated from both depots and cultured in vitro to assess the lipid accumulation rate.SSAT and DSAT displayed different patterns of gene expression, mainly for metabolic and inflammatory genes, respectively. Detailed gene expression analysis indicated that several metabolic genes, including adiponectin, are preferentially expressed in SSAT, whereas inflammatory genes are over-expressed in DSAT. Despite a similar lipid accumulation rate in vitro, in vivo SSAT showed a significant adipocyte hypertrophy together with a significantly lower inflammatory infiltration and vascular vessel lumen mean size, when compared to DSAT.These data show that, SSAT and DSAT are functionally and morphologically different and emphasize the importance of considering independent these two adipose depots when investigating SAT biology and obesity complications.

Published
2012

41. Management of high blood pressure in children and adolescents: Recommendations of the European Society of hypertension [Manejo de la hipertensión arterial en niños y adolescentes: recomendaciones de la Sociedad Europeade Hipertensión]

Author

Lurbe, E. Cifkova, R. Cruickshank, J.K. Dillon, M.J. Ferreira, I. Invitti, C. Kuznetsova, T. Laurent, S. Mancia, G. Morales-Olivas, F. Rascher, W. Redon, J. Schaefer, F. Seeman, T. Stergiou, G. Wühl, E. Zanchetti, A.

Abstract

Hypertension in children and adolescents has been gaining ground in cardiovascular medicine, mainly due to the advances made in several areas of pathophysiological and clinical research. These guidelines arose from the consensus reached by specialists in the detection and control of hypertension in children and adolescents. Furthermore, these guidelines are a compendium of scientific data and the extensive clinical experience it contains represents the most complete information that doctors, nurses and families should take into account when making decisions. These guidelines, which stress the importance of hypertension in children and adolescents, and its contribution to the current epidemic of cardiovascular disease, should act as a stimulus for governments to develop a global effort for the early detection and suitable treatment of high pressure in children and adolescents. J Hypertens 27:1719-1742 Q 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins. © 2010 Asociación Española de Pediatría. Published by Elsevier España, S.L. All rights reserved.

Published
2010

46. Percutaneous transluminal angioplasty improves glucose control and quality of life in patients with critical limb ischemia

Author

Tolva, V, Casana, R, Lonati, L, Invitti, C, Bertoni, G, Bianchi, P, Cireni, L, Parati, G, TOLVA, VALERIO STEFANO, PARATI, GIANFRANCO, Tolva, V, Casana, R, Lonati, L, Invitti, C, Bertoni, G, Bianchi, P, Cireni, L, Parati, G, TOLVA, VALERIO STEFANO, and PARATI, GIANFRANCO

Abstract

AIM: To evaluate the benefit of endovascular peripheral revascularization on glucose control in patients with chronic limb ischemia. METHODS AND RESULTS: Over a 12 month period, 61 patients (41 male, range 49-88 years of age) presenting with critical limb ischemia (CLI) were treated according to the Trans Atlantic Inter Society Consensus (TASC II) guidelines. After discharge, all patients were asked to measure their glucose level three times daily, and glycated hemoglobin was checked monthly up to 12 months, as well as to fill a questionnaire to assess their Quality of Life (QoL). The revascularization procedure was successful in 90% of cases. Glycemic control and glycated hemoglobin in 22 diabetic patients subgroup were significantly improved after the treatment and remained stable over the follow-up period. There was a significant improvement in QoL that increased steadily from the operation and to reach a plateau after six months. CONCLUSIONS: Peripheral percutaneous angioplasty in subjects with CLI significantly improves glycemic control and ameliorates QoL. Revascularization positively effects also long-term diabetes control as well as QoL

Published
2012

47. Diagnosis and management of Cushing's syndrome: Results of an Italian multicentre study

Author

Invitti, C., Giraldi, F. P., De Martin, M., Cavagnini, F., Angeli, A., Terzolo, M., Belotti, G., Castello, R., Bertolissi, F., Borretta, G., Boscaro, M., Scarpa, E., Camanni, F., Mazza, E., Cantalamessa, L., Caviezel, F., Morricone, L., De Sanctis, C., DEGLI UBERTI, Ettore, Ferrari, C., Giustina, A., Jannì, A., Lo Coco, R., Letizia, C., Liuzzi, A., Ghiggi, M. R., Lo Cascio, V., Francia, G., Lombardi, G., Colao, A., Mancini, A., De Marinis, L., Mannelli, M., Mantero, F., Masini, A. M., Mazzi, C., Muggeo, M., Moghetti, P., Pinchera, A., Martino, E., Barletta, D., Rizzi, G., Santeusanio, F., Sciarra, F., Tosti Croce, C., Vezzadini, P., Toni, R., Zampa, G. A., and Sforza, A.

Subjects
endocrine system, medicine.medical_specialty, Immunoradiometric assay, Petrosal Sinus Sampling, business.industry, Endocrinology, Diabetes and Metabolism, Biochemistry (medical), Clinical Biochemistry, Stimulation, Hyperplasia, medicine.disease, Biochemistry, Inferior petrosal sinus sampling, Cushing syndrome, Basal (phylogenetics), Endocrinology, Internal medicine, medicine, Adrenal adenoma, business, hormones, hormone substitutes, and hormone antagonists
Abstract

The past 45 yr’ experience with Cushing’s syndrome (CS) has led to the awareness of its complex nature and, by the same token, brought about an increase in the diagnostic and therapeutic dilemmas. We carried out a retrospective multicentre study on the diagnostic work-up and treatment in 426 patients with CS, subdivided as follows: 288 with Cushing’s disease (CD), 80 with an adrenal adenoma, 24 with an adrenal carcinoma, 25 with ectopic ACTH and/or CRH secretion, and 9 with ACTH-independent nodular adrenal hyperplasia. Normal urinary free cortisol (UFC) values among multiple collections were recorded in about 10% of patients with CS. In 28% of patients with ACTH-independent CS, basal ACTH concentrations were within the normal range but did not respond to CRH stimulation. Measurement of ACTH levels by immunoradiometric assay, rather than by RIA, offered a greater chance of recognizing patients with ACTH-independent CS or ectopic secretion. A 50% increase in ACTH or cortisol levels after CRH yielded a diagn...

Published
1999

48. Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension

Author

Lurbe, E, Cifkova, R, Cuickshank, J, Dillon, M, Ferreira, I, Invitti, C, Kuznetsova, T, Laurent, S, Mancia, G, Morales Olivas, F, Rascher, W, Redon, J, Schaefer, F, Seeman, T, Stergiou, G, Wuhl, E, Zanchetti, A, Cifkova,R, Cuickshank, JK, Dillon, MJ, Zanchetti, A., MANCIA, GIUSEPPE, Lurbe, E, Cifkova, R, Cuickshank, J, Dillon, M, Ferreira, I, Invitti, C, Kuznetsova, T, Laurent, S, Mancia, G, Morales Olivas, F, Rascher, W, Redon, J, Schaefer, F, Seeman, T, Stergiou, G, Wuhl, E, Zanchetti, A, Cifkova,R, Cuickshank, JK, Dillon, MJ, Zanchetti, A., and MANCIA, GIUSEPPE

Abstract

Hypertension in children and adolescents has gained ground in cardiovascular medicine, thanks to the progress made in several areas of pathophysiological and clinical research. These guidelines represent a consensus among specialists involved in the detection and control of high blood pressure in children and adolescents. The guidelines synthesize a considerable amount of scientific data and clinical experience and represent best clinical wisdom upon which physicians, nurses and families should base their decisions. They call attention to the burden of hypertension in children and adolescents, and its contribution to the current epidemic of cardiovascular disease, these guidelines should encourage public policy makers, to develop a global effort to improve identification and treatment of high blood pressure among children and adolescents. © 2009 Wolters Kluwer Health Lippincott Williams & Wilkins.

Published
2009

49. The impact of the degree of obesity on the discrepancies between office and ambulatory blood pressure values in youth

Author

Lurbe, E, Invitti, C, Torro, I, Maronati, A, Aguilar, F, Sartorio, G, Redon, J, Parati, G, PARATI, GIANFRANCO, Lurbe, E, Invitti, C, Torro, I, Maronati, A, Aguilar, F, Sartorio, G, Redon, J, Parati, G, and PARATI, GIANFRANCO

Abstract

Objectives Obesity is an increasingly frequent problem among children and adolescents, and may lead to blood pressure (BP) increase. The aim of the present study was to assess the prevalence of hypertension, white-coat and masked hypertension in obese adolescents making systematic use of both office BP and 24-h ambulatory BP measurement. The impact of different degrees of obesity on BP and heart rate variability was also investigated. Methods Office and ambulatory BP were obtained in 285 overweight and obese Caucasian adolescents (11–18 years old) and in 180 age- and sex-matched controls. The extent of obesity was quantified using body mass index z score. Results A significant positive relationship between body mass index z score and both office and ambulatory systolic BP was found after adjusting for age and height in both boys and girls. Obese youths had not only higher BP levels, but also higher BP variability compared with controls. Among obese youths, 20.8% had abnormal BP conditions, 6.6% were white-coat hypertensives, 9.2% were masked hypertensives and 5% were sustained hypertensives. Conclusions The prevalence of these abnormal BP conditions, which can be identified thanks to ambulatory BP monitoring, further emphasizes the usefulness of this diagnostic tool in obese youths.

Published
2006

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