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

  • STATUS
    Not Recruiting
  • participants needed
    2000
  • sponsor
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Updated on 21 January 2021
metformin

Summary

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.

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.

Details
Condition Metabolic syndrome
Treatment Metformin Hydrochloride 850 MG Oral Tablet [Glucophage], Ludipress, mg stereate, micronized hydrated silica, talcum
Clinical Study IdentifierNCT02960711
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Last Modified on21 January 2021

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