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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]

Ludipress, mg stereate, micronized hydrated silica, talcum

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Fondazione IRCCS Istituto Nazionale Tumori

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

METFORMIN (1700MG/DAY) + LIFESTYLE

PLACEBO+ LIFESTYLE

METFORMIN (1700 mg/day) alone

PLACEBO alone

Arm Description

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

Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities

METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day)

Placebo: (two identical tablets) according to the blind assignment

Outcomes

Primary Outcome Measures

Total incidence of age related chronic diseases

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

Effect of the intervention on total mortality and on the incidence of specific chronic diseases.

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

Full Information

NCT ID

NCT02960711

First Posted

October 21, 2016

Last Updated

September 27, 2021

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

1. Study Identification

Unique Protocol Identification Number

NCT02960711

Brief Title

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

Acronym

MeMeMe

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

METFORMIN (1700MG/DAY) + LIFESTYLE

Arm Type

Experimental

Arm Description

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

Arm Title

PLACEBO+ LIFESTYLE

Arm Type

Placebo Comparator

Arm Description

Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities

Arm Title

METFORMIN (1700 mg/day) alone

Arm Type

Experimental

Arm Description

METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day)

Arm Title

PLACEBO alone

Arm Type

Placebo Comparator

Arm Description

Placebo: (two identical tablets) according to the blind assignment

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]

Intervention Type

Drug

Intervention Name(s)

Ludipress, mg stereate, micronized hydrated silica, talcum

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

Total incidence of age related chronic diseases

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Effect of the intervention on total mortality and on the incidence of specific chronic diseases.

Description

Time Frame

8-10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco Berrino, MD

Organizational Affiliation

Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Istituto Nazionale Tumori

City

Milan

ZIP/Postal Code

20133

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35333878

Citation

Baldassari I, Oliverio A, Krogh V, Bruno E, Gargano G, Cortellini M, Casagrande A, Di Mauro MG, Venturelli E, Del Sette Cerulli D, Manuela B, Berrino F, Pasanisi P. Recruitment in randomized clinical trials: The MeMeMe experience. PLoS One. 2022 Mar 25;17(3):e0265495. doi: 10.1371/journal.pone.0265495. eCollection 2022.

Results Reference

derived

PubMed Identifier

30794607

Citation

Cortellini M, Casagrande A, Fornaciari G, Del Sette D, Gargano G, Di Mauro MG, Saibene G, Bruno E, Villarini A, Venturelli E, Berrino F, Baldassari I, Oliverio A, Pasanisi P. A management system for randomized clinical trials: A novel way to supply medication. PLoS One. 2019 Feb 22;14(2):e0212475. doi: 10.1371/journal.pone.0212475. eCollection 2019.

Results Reference

derived

PubMed Identifier

28740367

Citation

Cortellini M, Berrino F, Pasanisi P. "Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial. Patient Prefer Adherence. 2017 Jul 6;11:1127-1132. doi: 10.2147/PPA.S135412. eCollection 2017.

Results Reference

derived

PubMed Identifier

28106245

Citation

Pasanisi P, Gargano G, Gaetana Di Mauro M, Cortellini M, Casagrande A, Villarini A, Bruno E, Roveda E, Saibene G, Venturelli E, Berrino F. A randomized controlled trial of Mediterranean diet and metformin to prevent age-related diseases in people with metabolic syndrome. Tumori. 2018 Mar-Apr;104(2):137-142. doi: 10.5301/tj.5000599. Epub 2018 May 8.

Results Reference

derived

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

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