Chronic Metformin Treatment Induces a Dietary Restriction-like State in Overweight Human
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The differences of gene expression profile among 3 groups.
研究概览
简要总结
The fact that metformin treatment has been associated with reduced risk of cancer and cardiovascular disease raises the possibility of a beneficial role of metformin for other age-related diseases. The actions of metformin resemble the effects of calorie restriction (CR) to some extent, and microarray analyses have shown that metformin induces a gene expression profile that aligns with that of CR in animal. The aim of the study is to investigate whether metformin treatment can induce dietary restriction-like state in human.
Sixty overweight subjects will be included in this study, and participants will be divided 3 groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet group, and CR group. All subjects will be treated 6 months. At the end of this study, blood samples and muscle samples will be obtained.
详细描述
Blood samples will be obtained from all individuals. blood lipids, inflammation markers, insulin, glucose, leptin,adiponectin, ala aminotransferase, asp aminotransferase, creatine phosphokinase,lactate dehydrogenase, alkaline phosphatase,bilirubin, cyclo-oxygenase, citrate synthase, renal function, leukocyte telomere length ratio, and telomerase activity will be measured before and after the treatments.Also, hyperinsulinemic-euglycemic clamp will be performed before and after the treatments. Muscle samples will be obtained by biopsy for 9 individuals (3 cases from each group) at the end of the study. Microarray analysis will be performed for the gene expression profile from the muscle samples. Other protein expressions such asadenosine monophosphate-activated protein kinase (AMPK), peroxisome proliferator-activated receptor coactivator 1a (PGC-1a) activity,will be checked by Western blot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overweight
排除标准
- •Using any other drugs
- •< 18 years old
- •> 60 years old
- •Mental disorders
- •Surgery history for abdomen
研究组 & 干预措施
CR group
Calorie restriction diet will be given to this group.
干预措施: Calorie restriction (Behavioral)
Metformin group
Metformin 0.85 twice daily for 6 months
干预措施: metformin 0.85 twice daily for 6 months (Drug)
结局指标
主要结局
The differences of gene expression profile among 3 groups.
时间窗: 6 months
The gene expression profile will be checked by microarray, and compared the number differences of pathways among 3 groups.
次要结局
- The differences of insulin sensitivity in 3 groups(6 months)
研究者
Xiang Guang-da
Director of Endocrinol Dept.
Wuhan General Hospital of Guangzhou Military Command