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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| METFORMIN (1700MG/DAY) + LIFESTYLE | Experimental | 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+ LIFESTYLE | Placebo Comparator | Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities |
|
| METFORMIN (1700 mg/day) alone | Experimental | METFORMIN: 2 tablets per day, one at breakfast (or lunch) and one at dinner, of either metformin (two 850 mg tablets/day) |
|
| PLACEBO alone | Placebo Comparator | Placebo: (two identical tablets) according to the blind assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Hydrochloride 850 MG Oral Tablet [Glucophage] | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Franco Berrino, MD | Fondazione IRCCS ISTITUTO NAZIONALE TUMORI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35333878 | Derived | 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. | |
| 30794607 |
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| Ludipress, mg stereate, micronized hydrated silica, talcum |
| Drug |
Tablet |
|
| 8-10 years |
| 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. |
| 28740367 | Derived | 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. |
| 28106245 | Derived | 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. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013607 | Tablets |
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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