A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Composite the efficacy of metformin in intervening aging
研究概览
简要总结
The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging.
详细描述
Subjects in both the metformin hydrochloride extended-release tablets treatment group and the placebo group received two tablets (500 mg each) once daily after dinner, continuing for a one-year period of drug intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin hydrochloride
1000 mg/day Metformin hydrochloride extended-release tablets
干预措施: Metformin Hydrochloride tablet (Drug)
Placebo group
1000 mg/day placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Composite the efficacy of metformin in intervening aging
时间窗: Baseline - 12 month
1. Metformin delay aging related sensitive indicators (2), such as SA\*, ancient virus \*. 2. Metformin inhibits markers of inflammation in the body (4), such as C1 protein \*, CRP, CXCL9, TNFa. 3. Metformin improved immune cell-related indicators (10\*), such as T1/T2/L gene expression. 4. Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1\* and APOX2\*. 5. Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc.
次要结局
- Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.(Baseline - 12 month)