Randomized Controlled Trial of Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Total incidence of age related chronic diseases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
PLACEBO+ LIFESTYLE
Placebo: (two identical tablets) according to the blind assignment + participation in the life-style intervention activities
干预措施: Ludipress, mg stereate, micronized hydrated silica, talcum (Drug)
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
干预措施: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage] (Drug)
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)
干预措施: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage] (Drug)
PLACEBO alone
Placebo: (two identical tablets) according to the blind assignment
干预措施: Ludipress, mg stereate, micronized hydrated silica, talcum (Drug)
结局指标
主要结局
Total incidence of age related chronic diseases
时间窗: 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
次要结局
- Effect of the intervention on total mortality and on the incidence of specific chronic diseases.(8-10 years)