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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

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE November 10, 2016
Last Update Posted Date November 10, 2016
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
Official Title  ICMJE Randomized Controlled Trial of Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]
  • Drug: Ludipress, mg stereate, micronized hydrated silica, talcum
    Tablet
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Ludipress, mg stereate, micronized hydrated silica, talcum
  • 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)
    Intervention: Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]
  • Placebo Comparator: PLACEBO alone
    Placebo: (two identical tablets) according to the blind assignment
    Intervention: Drug: Ludipress, mg stereate, micronized hydrated silica, talcum
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2016)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02960711
Other Study ID Numbers  ICMJE INT 85-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franco Berrino, MD Fondazione IRCCS Istituto Nazionale Tumori
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP