Final Report Summary - MEMEME (Randomized controlled trial of metformin and dietary restriction to prevent age-related morbid events in people with metabolic syndrome)
The MeMeMe project (Metabolic syndrome, Mediterranean diet and Metformin) is a randomized controlled trial to test the effect of lifestyle intervention (Mediterranean diet and physical activity) and/or treatment with 1700 mg/day of metformin (MET) on the incidence and mortality for age-related chronic diseases (ArCD) in volunteers at high risk because of age (50-79 at the start of the study) and the presence of metabolic syndrome (MS). The MS is defined by the presence of at least 3 of the following factors: abdominal obesity, hypertension, high glycaemia, high triglycerides and low HDL cholesterol. ArCD include: diabetes, cardiovascular diseases, cancers, neurodegenerative diseases and autoimmune diseases.
1380 patients with metabolic syndrome were randomized in four groups:
1. MET + active lifestyle intervention (341)
2. placebo + active lifestyle intervention (353)
3. MET alone (363)
4. placebo alone (323).
Over 2.2 years average follow-up, volunteers included in the placebo group experienced a significant two fold higher risk of developing an ArCD with respect to the volunteers treated with MET. The difference between the two groups was explained by the occurrence of diabetes, with 24 cases in the placebo group versus zero cases in the MET group. This is a dramatic difference that will modify the guidelines of the treatment of the MS. By the time being no significant difference has yet been observed for other ArCD and for lifestyle intervention. The follow-up is still ongoing.
1380 patients with metabolic syndrome were randomized in four groups:
1. MET + active lifestyle intervention (341)
2. placebo + active lifestyle intervention (353)
3. MET alone (363)
4. placebo alone (323).
Over 2.2 years average follow-up, volunteers included in the placebo group experienced a significant two fold higher risk of developing an ArCD with respect to the volunteers treated with MET. The difference between the two groups was explained by the occurrence of diabetes, with 24 cases in the placebo group versus zero cases in the MET group. This is a dramatic difference that will modify the guidelines of the treatment of the MS. By the time being no significant difference has yet been observed for other ArCD and for lifestyle intervention. The follow-up is still ongoing.