Pilot Study on Evaluating the Geroprotective Effect of Metformin

Phase 2

Not yet recruiting

• Conditions: Metformin; Aging
• Interventions: Drug: Metformin Hydrochloride tablet; Drug: Placebo

• Registration Number: NCT06459310
• Lead Sponsor: Xuanwu Hospital, Beijing

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Start: 2024-06-30
• Primary Completion: 2026-09-30
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin hydrochloride	Metformin Hydrochloride tablet	1000 mg/day Metformin hydrochloride extended-release tablets
Placebo group	Placebo	1000 mg/day placebo

Primary Outcome Measures

Name	Time	Method
Composite the efficacy of metformin in intervening aging	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 Outcome Measures

Name	Time	Method
Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.	Baseline - 12 month	1. Aging atlas-R, PBMC RNA profiling, \>5% DEGs.; 2. Aging atlas-P, proteomic profiling, \>5% DEPs.; 3. Aging atlas-M, metabolic profiling, \>5% metabolites.; 4. Aging atlas-B, metagenomic profiling, \>5% microbiotas.; 5. Reduce human biological age complex parameters.

Trial Locations

Locations (1)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China