metabolic syndrome
Conditions
Interventions
Trade Name: GLUCOPHAGE
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 1115-70-4
Current Sponsor code: MeMeMe
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg mil
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion 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 metabolic syndrome. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: -Dignosed diabetes (or baseline fasting glycemia above 7 mmol/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, we will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies. - Conditions that controindicate the use of MET because may favour lactic acidosis: Renal, cardiac, hepatic, or respiratory insufficiency, serum creatinine > 124 µmol/L, or proteinuria. Curent treatment with K-sparing diuretics, or with proton pump inhibitors. Excessive alcohol consumption. -Distressing side effects of MET treatment, such as nausea and diarrhoea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the 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 age-related chronic diseases ;Secondary Objective: Evaluate the effect of the intervention on total mortality and on the incidence of specific chronic diseases (diabetes, myocardial infarction, stroke, cancers, and others).;Primary end point(s): Total incidence of age related chronic diseases. We will retrieve records for all Age related chronic diseases but we will first concentrate the analysis on cancer, coronary heart disease, stroke, and diabetes;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total mortality and incidence of specific chronic diseases;Timepoint(s) of evaluation of this end point: A longer follow-up, of the order of 8-10 years will be necessary to analyse the incidence of specific chronic diseases | — |
Countries
Italy
Contacts
Public ContactSC Epidemiologia e Prevenzione
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed