Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome (MeMeMe)
Metabolic Syndrome
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for men, plus at least two other factors among those defining the MetS
Exclusion Criteria:
- Diagnosed diabetes (or baseline fasting glycemia above 7mmol/L at baseline examination)
- Cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment
- Excessive frailty: in absence of agreed-upon measurements parameters and cutoff points, the investigator will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies
Conditions that contraindicate the use of MET because might favour lactic acidosis:
- Renal, cardiac, hepatic, or respiratory insufficiency
- Serum creatinine <124μmol/L, or proteinuria at baseline examination
- Current treatment with K-sparing diuretics, or with proton pump inhibitors
- Excessive alcohol consumption
- Distressing side effects of MET treatment. Nausea and diarrhoea typically occur in about one third of patients receiving MET for the first time at full dose. To avoid dropouts for gastrointestinal discomfort we will treat all volunteers with half the planned dose for one month in order to exclude intolerant subjects before randomization. Participants randomized in the intervention group will continue to take half a dose for one month and then shift to the full dose.
Sites / Locations
- Fondazione IRCCS Istituto Nazionale Tumori
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
METFORMIN (1700MG/DAY) + LIFESTYLE
PLACEBO+ LIFESTYLE
METFORMIN (1700 mg/day) alone
PLACEBO alone
METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day) + participation in the life-style intervention activities
Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities
METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day)
Placebo: (two identical tablets) according to the blind assignment