Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome (MeMeMe)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase

Completed

Phase 3

Conditions

Metabolic Syndrome

Treatments

Drug: Ludipress, mg stereate, micronized hydrated silica, talcum

Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]

Study type

Interventional

Funder types

Other

Identifiers

NCT02960711

INT 85-13

Details and patient eligibility

About

Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent age-related chronic non-communicable diseases (ArCD).

The aim of the present study is to evaluate the effect of a comprehensive life-style intervention (including moderate physical activity and Mediterranean/macrobiotic diet with moderate calorie and protein restriction), and of treatment with Metformin (a calorie restriction mimetic drug) for the prevention of ArCD.

Full description

Phase III randomized controlled trial on men and women with MetS to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent ArCD.

Design:

2x2 factorial: 2,000 volunteers will be randomized in four equal groups of 500 each, and allocated to the following treatments: METFORMIN (1700MG/DAY) + ACTIVE LIFESTYLE INTERVENTION PLACEBO + ACTIVE LIFESTYLE INTERVENTION METFORMIN (1700 mg/day) alone PLACEBO alone The metformin /placebo component of the study will be double blind.

Enrollment

1,600 patients

Sex

All

Ages

55 to 74 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

1,600 participants in 4 patient groups, including a placebo group

METFORMIN (1700MG/DAY) + LIFESTYLE

Experimental group

Description:

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

Treatment:

Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]

PLACEBO+ LIFESTYLE

Placebo Comparator group

Description:

Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities

Treatment:

Drug: Ludipress, mg stereate, micronized hydrated silica, talcum

METFORMIN (1700 mg/day) alone

Experimental group

Description:

METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day)