Metformin Treatment With or Without Mediterranean Diet for the Prevention of Age-Related Diseases in People With Metabolic Syndrome: The MeMeMe Randomized Trial.

OBJECTIVE: The Metformin and Dietary Restriction to Prevent Age-Related Morbid Events in People With Metabolic Syndrome (MeMeMe) trial tested whether 1,700 mg/day metformin (MET) with or without a Mediterranean diet (MedDiet) intervention could reduce the cumulative incidence of major noncommunicable diseases in people with metabolic syndrome. RESEARCH DESIGN AND METHODS: A total of 1,442 participants were randomly assigned to one of four interventions: 1) MET (1,700 mg/day) plus MedDiet intervention (MET+MedDiet); 2) placebo plus MedDiet intervention; 3) MET (1,700 mg/day) alone; and 4) placebo alone. Participants were followed up for 3 years on average. The primary outcome was the cumulative incidence of major noncommunicable diseases (including type 2 diabetes, cardiovascular diseases, and cancer). Secondary outcomes were the incidence of type 2 diabetes and the changing prevalence of metabolic syndrome. RESULTS: The crude incidence of the major noncommunicable diseases was 6.7 cases per 100 person-years in theMET+MedDiet group, 6.9 in theMET alone group, 13.3 in the placebo plus MedDiet group, and 11.3 in the placebo group. The differences were fully explained by the reduction of type 2 diabetes, which was 80% and 92% lower in the MET andMET+MedDiet groups, respectively, compared with placebo. CONCLUSIONS: The use of 1,700 mg/day MET is effective to prevent diabetes in people selected on the basis of metabolic syndrome. [ABSTRACT FROM AUTHOR]