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 MeMeMe trial tested whether 1700 mg/day of metformin (MET) with or without an intervention of Mediterranean diet (MedDiet) can reduce the cumulative incidence of major non-communicable diseases in people with metabolic syndrome.

RESEARCH DESIGN AND METHODS

1442 participants were randomly assigned to one of four interventions:

- MET (1700 mg/day)+MedDiet intervention;

- Placebo+MedDiet intervention;

- MET (1700 mg/day) alone;

- Placebo alone.

Participants were followed-up for 3 years on average. The primary outcome was the cumulative incidence of major non-communicable 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 non-communicable diseases was 6.7 cases per 100 person-year in the MET+MedDiet group, 6.9 in the MET, 13.3 in the placebo+MedDiet, and 11.3 in the placebo. The difference was totally explained by the reduction of type 2 diabetes, which was 80% and 92% lower in the MET and MET+MedDiet groups respectively compared to placebo.

CONCLUSIONS

The use of 1700 mg/day of MET is effective to prevent diabetes in people selected on the basis of metabolic syndrome.