Effects of a mediterranean eating plan on the need for glucose-lowering medications in participants with type 2 diabetes: a subgroup analysis of the PREDIMED trial

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• dc.contributor.author Basterra-Gortari, F. Javier
• dc.contributor.author Ruiz-Canela, Miguel
• dc.contributor.author Martínez-González, Miguel Ángel, 1957-
• dc.contributor.author Babio, Nancy
• dc.contributor.author Sorlí, José Vicente
• dc.contributor.author Fitó Colomer, Montserrat
• dc.contributor.author Ros, Emilio
• dc.contributor.author Gómez-Gracia, Enrique
• dc.contributor.author Fiol, Miquel
• dc.contributor.author Lapetra, José
• dc.contributor.author Estruch, Ramón
• dc.contributor.author Serra-Majem, Luis
• dc.contributor.author Pinto, Xavier
• dc.contributor.author González, José I.
• dc.contributor.author Bulló, Mònica
• dc.contributor.author Castañer, Olga
• dc.contributor.author Alonso-Gómez, Ángel
• dc.contributor.author Forga, Luis
• dc.contributor.author Arós, Fernando
• dc.contributor.author PREDIMED investigators
• dc.date.accessioned 2019-12-03T07:56:34Z
• dc.date.available 2019-12-03T07:56:34Z
• dc.date.issued 2019
• dc.description.abstract OBJECTIVE: To examine the effects of two Mediterranean eating plans (Med-EatPlans) versus a low-fat eating plan on the need for glucose-lowering medications. RESEARCH DESIGN AND METHODS: From the Prevención con Dieta Mediterránea (PREDIMED) trial, we selected 3,230 participants with type 2 diabetes at baseline. These participants were randomly assigned to one of three eating plans: Med-EatPlan supplemented with extra-virgin olive oil (EVOO), Med-EatPlan supplemented with mixed nuts, or a low-fat eating plan (control). In a subgroup (15%), the allocation was done in small clusters instead of using individual randomization, and the clustering effect was taken into account in the statistical analysis. In multivariable time-to-event survival models, we assessed two outcomes: 1) introduction of the first glucose-lowering medication (oral or injectable) among participants on lifestyle management at enrollment and 2) insulin initiation. RESULTS: After a median follow-up of 3.2 years, in multivariable analyses adjusting for baseline characteristics and propensity scores, the hazard ratios (HRs) of starting a first glucose-lowering medication were 0.78 (95% CI 0.62-0.98) for Med-EatPlan + EVOO and 0.89 (0.71-1.12) for Med-EatPlan + nuts, compared with the control eating plan. After a median follow-up of 5.1 years, the adjusted HRs of starting insulin treatment were 0.87 (0.68-1.11) for Med-EatPlan + EVOO and 0.89 (0.69-1.14) for Med-EatPlan + nuts compared with the control eating plan. CONCLUSIONS: Among participants with type 2 diabetes, a Med-EatPlan + EVOO may delay the introduction of new-onset glucose-lowering medications. The Med-EatPlan did not result in a significantly lower need for insulin.
• dc.description.sponsorship The supplemental foods used in the study were donated by Patrimonio Comunal Olivarero and Hojiblanca, Madrid, Spain (EVOO); the California Walnut Commission, Sacramento, CA (walnuts); and Borges SA (almonds) and La Morella Nuts (hazelnuts), Reus, Spain. The PREDIMED trial was supported by Instituto de Salud Carlos III, the official funding agency for biomedical research of the Spanish government, through grants provided to research networks specifically developed for the trial (RTIC RD 06/0045 [coordinator: M.A.M.-G.] and RTIC G03/140 [coordinator: R.E.]). All investigators of the PREDIMED trial belong to CIBER, an initiative of Instituto de Salud Carlos III. The authors also acknowledge grants from the National Institutes of Health Clinical Center (1R01-HL-118264-01 and 1R01-DK-102896), Fondo de Investigación Sanitaria–Fondo Europeo de Desarrollo Regional (PI04/0233, PI05/0976, PI07/0240, PI10/01407, PI10/02658, PI11/00049, PI11/02505, and AGL2010-22319-C03-03), Consejería de Salud Junta de Andalucía (PI0105/2007), and the Generalitat Valenciana, Valencia, Spain (ACOMP/2013/165 and COMP/2013/159).
• dc.format.mimetype application/pdf
• dc.identifier.citation Basterra-Gortari FJ, Ruiz-Canela M, Martínez-González MA, Babio N, Sorlí JV, Fito M. et al. Effects of a mediterranean eating plan on the need for glucose-lowering medications in participants with type 2 diabetes: a subgroup analysis of the PREDIMED trial. Diabetes Care. 2019 Aug;42(8):1390-1397. DOI 10.2337/dc18-2475
• dc.identifier.doi http://dx.doi.org/10.2337/dc18-2475
• dc.identifier.issn 0149-5992
• dc.identifier.uri http://hdl.handle.net/10230/43056
• dc.language.iso eng
• dc.publisher American Diabetes Association
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PN/AGL2010-22319-C03-03
• dc.rights © American Diabetes Association. This is an author-created, uncopyedited electronic version of an article accepted for publication in Diabetes Care. The American Diabetes Association (ADA), publisher of Diabetes Care, is not responsible for any errors or omissions in this version of the manuscript or any version derived from it by third parties. The definitive publisher-authenticated version will be available in a future issue of Diabetes in print and online at http://diabetes.diabetesjournals.org.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.subject.other Dieta -- Mediterrània, Regió de la
• dc.subject.other Diabetis
• dc.title Effects of a mediterranean eating plan on the need for glucose-lowering medications in participants with type 2 diabetes: a subgroup analysis of the PREDIMED trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/acceptedVersion