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

Identifier:  imarina:5779489

Handle: https://hdl.handle.net/20.500.11797/imarina5779489

Authors:  Basterra-Gortari, FJ; Ruiz-Canela, M; Martínez-González, MA; Babio, N; Sorlí, JV; Fito, M; Ros, E; Gómez-Gracia, E; Fiol, M; Lapetra, J; Estruch, R; Serra-Majem, L; Pinto, X; González, JI; Bulló, M; Castañer, O; Alonso-Gómez, A; Forga, L; Arós, F

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 Prevencion con Dieta Mediterranea (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.