BACKGROUND: Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated. OBJECTIVE: To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years). DESIGN: Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING:Primary care centers in Spain. PARTICIPANTS: Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk. INTERVENTION: Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included. MEASUREMENTS: Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome). RESULTS: During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet. LIMITATIONS: Randomization was not stratified by diabetes status. Withdrawals were greater in the control group. CONCLUSION: A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III.
RCT Entities:
BACKGROUND: Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated. OBJECTIVE: To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years). DESIGN: Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING: Primary care centers in Spain. PARTICIPANTS: Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk. INTERVENTION: Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included. MEASUREMENTS: Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome). RESULTS: During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet. LIMITATIONS: Randomization was not stratified by diabetes status. Withdrawals were greater in the control group. CONCLUSION: A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III.
Authors: Ruth Blanco-Rojo; Juan F Alcala-Diaz; Suzan Wopereis; Pablo Perez-Martinez; Gracia M Quintana-Navarro; Carmen Marin; Jose M Ordovas; Ben van Ommen; Francisco Perez-Jimenez; Javier Delgado-Lista; Jose Lopez-Miranda Journal: Diabetologia Date: 2015-10-16 Impact factor: 10.122
Authors: Katherine Esposito; Maria Ida Maiorino; Giuseppe Bellastella; Demosthenes B Panagiotakos; Dario Giugliano Journal: Endocrine Date: 2016-07-09 Impact factor: 3.633
Authors: Carmen Sayón-Orea; Cristina Razquin; Mónica Bulló; Dolores Corella; Montserrat Fitó; Dora Romaguera; Jesús Vioque; Ángel M Alonso-Gómez; Julia Wärnberg; J Alfredo Martínez; Luís Serra-Majem; Ramón Estruch; Francisco J Tinahones; José Lapetra; Xavier Pintó; Josep A Tur; José López-Miranda; Aurora Bueno-Cavanillas; Miguel Delgado-Rodríguez; Pilar Matía-Martín; Lidia Daimiel; Vicente Martín Sánchez; Josep Vidal; Clotilde Vázquez; Emilio Ros; Miguel Ruiz-Canela; José V Sorlí; Olga Castañer; Miquel Fiol; Eva M Navarrete-Muñoz; Fernando Arós; Enrique Gómez-Gracia; M Angeles Zulet; Almudena Sánchez-Villegas; Rosa Casas; Rosa Bernal-López; José M Santos-Lozano; Emili Corbella; Cristina Bouzas; Ana García-Arellano; Josep Basora; Eva M Asensio; Helmut Schröder; Manuel Moñino; Manoli García de la Hera; Lucas Tojal-Sierra; Estefanía Toledo; Andrés Díaz-López; Albert Goday; Jordi Salas-Salvadó; Miguel A Martínez-González Journal: JAMA Date: 2019-10-15 Impact factor: 56.272
Authors: Marta Guasch-Ferré; José L Santos; Miguel A Martínez-González; Clary B Clish; Cristina Razquin; Dong Wang; Liming Liang; Jun Li; Courtney Dennis; Dolores Corella; Carlos Muñoz-Bravo; Dora Romaguera; Ramón Estruch; José Manuel Santos-Lozano; Olga Castañer; Angel Alonso-Gómez; Luis Serra-Majem; Emilio Ros; Sílvia Canudas; Eva M Asensio; Montserrat Fitó; Kerry Pierce; J Alfredo Martínez; Jordi Salas-Salvadó; Estefanía Toledo; Frank B Hu; Miguel Ruiz-Canela Journal: Am J Clin Nutr Date: 2020-04-01 Impact factor: 7.045
Authors: Carolyn R Hofe; Limin Feng; Dominique Zephyr; Arnold J Stromberg; Bernhard Hennig; Lisa M Gaetke Journal: Nutr Res Date: 2014-02-10 Impact factor: 3.315
Authors: Edward Yu; Miguel Ruiz-Canela; Cristina Razquin; Marta Guasch-Ferré; Estefania Toledo; Dong D Wang; Christopher Papandreou; Courtney Dennis; Clary Clish; Liming Liang; Monica Bullo; Dolores Corella; Montserrat Fitó; Mario Gutiérrez-Bedmar; José Lapetra; Ramón Estruch; Emilio Ros; Montserrat Cofán; Fernando Arós; Dora Romaguera; Lluis Serra-Majem; Jose V Sorlí; Jordi Salas-Salvadó; Frank B Hu; Miguel A Martínez-González Journal: Diabetes Obes Metab Date: 2018-10-02 Impact factor: 6.577