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

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ClinicalTrials.gov Identifier: NCT02960711
Recruitment Status : Unknown
Verified October 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : November 10, 2016
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief 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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage] Drug: Ludipress, mg stereate, micronized hydrated silica, talcum Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
Study Start Date : February 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: METFORMIN (1700MG/DAY) + LIFESTYLE
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
Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]
Placebo Comparator: PLACEBO+ LIFESTYLE
Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities
Drug: Ludipress, mg stereate, micronized hydrated silica, talcum
Tablet

Experimental: METFORMIN (1700 mg/day) alone
METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day)
Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]
Placebo Comparator: PLACEBO alone
Placebo: (two identical tablets) according to the blind assignment
Drug: Ludipress, mg stereate, micronized hydrated silica, talcum
Tablet




Primary Outcome Measures :
  1. Total incidence of age related chronic diseases [ Time Frame: 5 years ]
    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


Secondary Outcome Measures :
  1. Effect of the intervention on total mortality and on the incidence of specific chronic diseases. [ Time Frame: 8-10 years ]

    The measure is a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group).

    The outcome measure describes multiple assessments with potentially different Units of Measure as indicated:

    Waist circumference: cm Glycemia: mg/dL Blood pressure: mmHg Total cholesterol, HDL cholesterol: mg/dL Triglycerides: mg/dL




Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960711


Contacts
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Contact: Franco Berrino, MD +390223903515 Franco.berrino@istitutotumori.mi.it
Contact: Patrizia Pasanisi, MD +390223903513 Patrizia.pasanisi@istitutotumori.mi.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale Tumori Recruiting
Milan, Italy, 20133
Contact: Franco Berrino, MD    +390223903515    Franco.berrino@istitutotumori.mi.it   
Contact: Patrizia Pasanisi, MD    +390223903513    trialcenter@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Franco Berrino, MD Fondazione IRCCS Istituto Nazionale Tumori

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02960711     History of Changes
Other Study ID Numbers: INT 85-13
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs