Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type 2 Diabetes-TOSCA.IT Study

Pasta is a refined carbohydrate with a low glycemic index. Whether pasta shares the metabolic advantages of other low glycemic index foods has not really been investigated. The aim of this study is to document, in people with type-2 diabetes, the consumption of pasta, the connected dietary habits, and the association with glucose control, measures of adiposity, and major cardiovascular risk factors

Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type2 Diabetes-TOSCA.IT Study.

Background: Pasta is a refined carbohydrate with a low glycemic index. Whether pasta shares the metabolic advantages of other low glycemic index foods has not really been investigated. The aim of this study is to document, in people with type-2 diabetes, the consumption of pasta, the connected dietary habits, and the association with glucose control, measures of adiposity, and major cardiovascular risk factors. Methods: We studied 2562 participants. The dietary habits were assessed with the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Sex-specific quartiles of pasta consumption were created in order to explore the study aims. Results: A higher pasta consumption was associated with a lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber. Glucose control, body mass index, prevalence of obesity, and visceral obesity were not significantly different across the quartiles of pasta intake. No relation was found with LDL cholesterol and triglycerides, but there was an inverse relation with HDL-cholesterol. Systolic blood pressure increased with pasta consumption; but this relation was not confirmed after correction for confounders. Conclusions: In people with type-2 diabetes, the consumption of pasta, within the limits recommended for total carbohydrates intake, is not associated with worsening of glucose control, measures of adiposity, and major cardiovascular risk factors. Keywords: body mass index; cardiovascular risk factors; dietary habits; glucose control; pasta consumption; type 2 diabetes

Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type 2 Diabetes-TOSCA.IT Study

Pasta is a refined carbohydrate with a low glycemic index. Whether pasta shares the metabolic advantages of other low glycemic index foods has not really been investigated. The aim of this study is to document, in people with type-2 diabetes, the consumption of pasta, the connected dietary habits, and the association with glucose control, measures of adiposity, and major cardiovascular risk factors

Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study

none37nononeVitale, Marilena; Vaccaro, Olga; Masulli, Maria; Bonora, Enzo; Del Prato, Stefano; Giorda, Carlo B.; Nicolucci, Antonio; Squatrito, Sebastiano; Auciello, Stefania; Babini, Anna C.; Bani, Laura; Buzzetti, Raffaella; Cannarsa, Emanuela; Cignarelli, Mauro; Cigolini, Massimo; Clemente, Gennaro; Cocozza, Sara; Corsi, Laura; D'Angelo, Federica; Dall'Aglio, Elisabetta; Di Cianni, Graziano; Fontana, Lucia; Gregori, Giovanna; Grioni, Sara; Giordano, Carla; Iannarelli, Rossella; Iovine, Ciro; Lapolla, Annunziata; Lauro, Davide; Laviola, Luigi; Mazzucchelli, Chiara; Signorini, Stefano; Tonutti, Laura; Trevisan, Roberto; Zamboni, Chiara; Riccardi, Gabriele; Rivellese, Angela AVitale, Marilena; Vaccaro, Olga; Masulli, Maria; Bonora, Enzo; Del Prato, Stefano; Giorda, Carlo B.; Nicolucci, Antonio; Squatrito, Sebastiano; Auciello, Stefania; Babini, Anna C.; Bani, Laura; Buzzetti, Raffaella; Cannarsa, Emanuela; Cignarelli, Mauro; Cigolini, Massimo; Clemente, Gennaro; Cocozza, Sara; Corsi, Laura; D'Angelo, Federica; Dall'Aglio, Elisabetta; Di Cianni, Graziano; Fontana, Lucia; Gregori, Giovanna; Grioni, Sara; Giordano, Carla; Iannarelli, Rossella; Iovine, Ciro; Lapolla, Annunziata; Lauro, Davide; Laviola, Luigi; Mazzucchelli, Chiara; Signorini, Stefano; Tonutti, Laura; Trevisan, Roberto; Zamboni, Chiara; Riccardi, Gabriele; Rivellese, Angela A

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

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50\ue2\u80\u9375 years with type 2 diabetes inadequately controlled with metformin monotherapy (2\ue2\u80\u933 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15\ue2\u80\u9345 mg) or a sulfonylurea (5\ue2\u80\u9315 mg glibenclamide, 2\ue2\u80\u936 mg glimepiride, or 30\ue2\u80\u93120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57\uc2\ub73 months. The primary outcome occurred in 105 patients (1\uc2\ub75 per 100 person-years) who were given pioglitazone and 108 (1\uc2\ub75 per 100 person-years) who were given sulfonylureas (hazard ratio 0\uc2\ub796, 95% CI 0\uc2\ub774\ue2\u80\u931\uc2\ub726, p=0\uc2\ub779). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p<0\uc2\ub70001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups. Interpretation In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events. Funding Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society

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

none200nononeVitale, M.; Masulli, M.; Rivellese, A.A.; Bonora, E.; Cappellini, F.; Nicolucci, A.; Squatrito, S.; Antenucci, D.; Barrea, A.; Bianchi, C.; Bianchini, F.; Fontana, L.; Fornengo, P.; Giorgino, F.; Gnasso, A.; Mannucci, E.; Mazzotti, A.; Nappo, R.; Palena, A.P.; Pata, P.; Perriello, G.; Potenziani, S.; Radin, R.; Ricci, L.; Romeo, F.; Santini, C.; Scarponi, M.; Serra, R.; Timi, A.; Turco, A.A.; Vedovato, M.; Zavaroni, D.; Grioni, S.; Riccardi, G.; Vaccaro, O; Rivellese, Angela Albarosa; Cocozza, Sara; Auciello, Stefania; Turco, Anna Amelia; Bonora, Enzo; Cigolini, Massimo; Pichiri, Isabella; Brangani, Corinna; Tomasetto, Elena; Perriello, Gabriele; Timi, Alessia; Squatrito, Sebastiano; Sinagra, Tiziana; Longhitano, Sara; Tropea, Vanessa; Ballardini, Giorgio; Babini, Anna Carla; Ripani, Raffaella; Gregori, Giovanna; Dolci, Maria; Bruselli, Laura; Salutini, Isabella; Mori, Mary; Baccetti, Fabio; Lapolla, Annunziata; Sartore, Giovanni; Burlina, Silvia; Chilelli, Nino Cristiano; Buzzetti, Raffaella; Venditti, Chiara; Potenziani, Stella; Carlone, Angela; Galluzzo†, Aldo; Giordano, Carla; Torregrossa, Vittoria; Corsi, Laura; Cuneo, Giacomo; Corsi, Simona; Tizio, Biagio; Clemente, Gennaro; Citro, Giuseppe; Natale, Maria; Salvatore, Vita; Di Cianni, Graziano; Lacaria, Emilia; Russo, Laura; Iannarelli, Rossella; de Gregorio, Antonella; Sciarretta, Filomena; D’Andrea, Settimio; Montani, Valeria; Cannarsa, Emanuela; Dolcetti, Katia; Cordera, Renzo; Bonabello, Laura Affinito; Mazzucchelli, Chiara; Giorda, Carlo Bruno; Romeo, Francesco; Bonetto, Caterina; Antenucci, Daniela; Baldassarre, Maria Pompea Antonia; Iovine, Ciro; Nappo, Rossella; Ciano, Ornella; Dall’Aglio, Elisabetta; Mancastroppa, Giovanni; Grimaldi, Franco; Tonutti, Laura; Boemi, Massimo; D’Angelo, Federica; Leotta, Sergio; Fontana, Lucia; Lauro, Davide; Rinaldi, Maria Elena; Cignarelli, Mauro; la Macchia, Olga; Fariello, Stefania; Tomasi, Franco; Zamboni, Chiara; Dozio, Nicoletta; Trevisan, Roberto; Scaranna, Cristiana; Del Prato, Stefano; Miccoli, Roberto; Bianchi, Cristina; Garofolo, Monia; Pugliese, Giuseppe; Salvi, Laura; Rangel, Graziela; Vitale, Martina; Anichini, Roberto; Tedeschi, Anna; Corsini, Elisa; Cucinotta, Domenico; Di Benedetto, Antonino; Giunta, Loretta; Ruffo, Maria Concetta; Bossi, Antonio Carlo; Carpinter, Rita; Dotta, Francesco; Ceccarelli, Elena; Bartolo, Paolo Di; Caselli, Chiara; Luberto, Alessandra; Santini, Costanza; Mazzotti, Arianna; Calbucci, Giovanni; Consoli, Agostino; Ginestra, Federica; Calabrese, Maria; Zogheri, Alessia; Ricci, Lucia; Giorgino, Francesco; Laviola, Luigi; Ippolito, Claudia; Tarantino, Lucia; Avogaro, Angelo; Vedovato, Monica; Gnasso, Agostino; Carallo, Claudio; Scicchitano, Caterina; Zavaroni, Donatella; Livraga, Stefania; Perin, Paolo Cavallo; Forrnengo, Paolo; Prinzis, Tania; de Cosmo, Salvatore; Palena, Antonio Pio; Bacci, Simonetta; Mannucci, Edoardo; Lamanna, Caterina; Pata, Pietro; Lettina, Gabriele; Aiello, Antimo; Barrea, Angelina; Lalli, Carlo; Scarponi, Maura; Franzetti, Ivano; Radin, Raffaella; Serra, Rosalia; Petrachi, Francesca; Asprino, Vincenzo; Capra, Claudio; Cigolini, Massimo; Forte, Elisa; Potenziani, Stella; Reggiani, Giulio Marchesini; Forlani, Gabriele; Montesi, Luca; Mazzella, Natalia; Piatti, Pier Marco; Monti, Lucilla; Stuccillo, Michela; Auletta, Pasquale; Petraroli, Ettore; Capobianco, Giuseppe; Romano, Geremia; Cutolo, Michele; de Simone, Giosetta; Caiazzo, Gennaro; Nunziata, Peppe; Sorrentino, Susy; Amelia, Umberto; Calatola, Pasqualino; Capuano, GelsominaVitale, M.; Masulli, M.; Rivellese, A. A.; Bonora, Enzo; Cappellini, F.; Nicolucci, A.; Squatrito, S.; Antenucci, D.; Barrea, A.; Bianchi, C.; Bianchini, FRANCESCA ANTONIA; Fontana, L.; Fornengo, P.; Giorgino, FRANCESCO LIBERO; Gnasso, A.; Mannucci, E.; Mazzotti, Alfredo; Nappo, R.; Palena, A. P.; Pata, P.; Perriello, G.; Potenziani, S.; Radin, R.; Ricci, Laura; Romeo, Francesco; Santini, C.; Scarponi, M.; Serra, Roberto; Timi, A.; Turco, A. A.; Vedovato, M.; Zavaroni, D.; Grioni, S.; Riccardi, Giovanna; Vaccaro, O; Rivellese, Angela Albarosa; Cocozza, Sara; Auciello, Stefania; Turco, Anna Amelia; Bonora, Enzo; Cigolini, Massimo; Pichiri, Isabella; Brangani, Corinna; Tomasetto, Elena; Perriello, Gabriele; Timi, Alessia; Squatrito, Sebastiano; Sinagra, Tiziana; Longhitano, Sara; Tropea, Vanessa; Ballardini, Giorgio; Babini, Anna Carla; Ripani, Raffaella; Gregori, Giovanna; Dolci, Maria; Bruselli, Laura; Salutini, Isabella; Mori, Mary; Baccetti, Fabio; Lapolla, Annunziata; Sartore, Giovanni; Burlina, Silvia; Chilelli, NINO CRISTIANO; Buzzetti, Raffaella; Venditti, Chiara; Potenziani, Stella; Carlone, Angela; Galluzzo†, Aldo; Giordano, Carla; Torregrossa, Vittoria; Corsi, Laura; Cuneo, Giacomo; Corsi, Simona; Tizio, Biagio; Clemente, Gennaro; Citro, Giuseppe; Natale, Maria; Salvatore, Vita; Di Cianni, Graziano; Lacaria, Emilia; Russo, Laura; Iannarelli, Rossella; de Gregorio, Antonella; Sciarretta, Filomena; D’Andrea, Settimio; Montani, Valeria; Cannarsa, Emanuela; Dolcetti, Katia; Cordera, Renzo; Bonabello, Laura Affinito; Mazzucchelli, Chiara; Giorda, Carlo Bruno; Romeo, Francesco; Bonetto, Caterina; Antenucci, Daniela; Baldassarre, Maria Pompea Antonia; Iovine, Ciro; Nappo, Rossella; Ciano, Ornella; Dall’Aglio, Elisabetta; Mancastroppa, Giovanni; Grimaldi, Franco; Tonutti, Laura; Boemi, Massimo; D’Angelo, Federica; Leotta, Sergio; Fontana, Lucia; Lauro, Davide; Rinaldi, Maria Elena; Cignarelli, Mauro; la Macchia, Olga; Fariello, Stefania; Tomasi, Franco; Zamboni, Chiara; Dozio, Nicoletta; Trevisan, Roberto; Scaranna, Cristiana; Del Prato, Stefano; Miccoli, Roberto; Bianchi, Cristina; Garofolo, Monia; Pugliese, Giuseppe; Salvi, Laura; Rangel, Graziela; Vitale, Martina; Anichini, Roberto; Tedeschi, Anna; Corsini, Elisa; Cucinotta, Domenico; Di Benedetto, Antonino; Giunta, Loretta; Ruffo, Maria Concetta; Bossi, Antonio Carlo; Carpinter, Rita; Dotta, Francesco; Ceccarelli, Elena; Bartolo, Paolo Di; Caselli, Chiara; Luberto, Alessandra; Santini, Costanza; Mazzotti, Arianna; Calbucci, Giovanni; Consoli, Agostino; Ginestra, Federica; Calabrese, Maria; Zogheri, Alessia; Ricci, Lucia; Giorgino, FRANCESCO LIBERO; Laviola, Luigi; Ippolito, Claudia; Tarantino, Lucia; Avogaro, Angelo; Vedovato, Monica; Gnasso, Agostino; Carallo, Claudio; Scicchitano, Caterina; Zavaroni, Donatella; Livraga, Stefania; Perin, Paolo Cavallo; Forrnengo, Paolo; Prinzis, Tania; de Cosmo, Salvatore; Palena, Antonio Pio; Bacci, Simonetta; Mannucci, Edoardo; Lamanna, Caterina; Pata, Pietro; Lettina, Gabriele; Aiello, Antimo; Barrea, Angelina; Lalli, Carlo; Scarponi, Maura; Franzetti, Ivano; Radin, Raffaella; Serra, Rosalia; Petrachi, Francesca; Asprino, Vincenzo; Capra, Claudio; Cigolini, Massimo; Forte, Elisa; Potenziani, Stella; Reggiani, Giulio Marchesini; Forlani, Gabriele; Montesi, Luca; Mazzella, Natalia; Piatti, Pier Marco; Monti, Lucilla; Stuccillo, Michela; Auletta, Pasquale; Petraroli, Ettore; Capobianco, Giuseppe; Romano, Geremia; Cutolo, Michele; de Simone, Giosetta; Caiazzo, Gennaro; Nunziata, Peppe; Sorrentino, Susy; Amelia, Umberto; Calatola, Pasqualino; Capuano, Gelsomin

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

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50â\u80\u9375 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes