Prevention of chronic diseases through diet and metformi

Phase 1

• Conditions: metabolic syndrome; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005427-32-IT
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-09
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified