NCT02960711

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,600 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 55 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]
DRUG	Ludipress, mg stereate, micronized hydrated silica, talcum	Tablet

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-11-10
• Last updated: 2021-09-28

Locations

1 site across 1 country: Italy