A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Composite the efficacy of metformin in intervening aging
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Metformin hydrochloride
1000 mg/day Metformin hydrochloride extended-release tablets
Intervention: Metformin Hydrochloride tablet (Drug)
Placebo group
1000 mg/day placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Composite the efficacy of metformin in intervening aging
Time Frame: 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.
Secondary Outcomes
- Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.(Baseline - 12 month)