Pilot Study on Evaluating the Geroprotective Effect of Metformin (AGE-M)

March 18, 2025 updated by: Xuanwu Hospital, Beijing

A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
        • Contact:
        • Contact:
          • Guoguang Zhao, professor
        • Contact:
          • Guanghui Liu, professor
        • Contact:
          • Jing Li, professor
        • Contact:
          • Weiqi Zhang, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria：

  1. Male
  2. Age 55-65; 18-28;
  3. Able to understand and execute instructions;
  4. After reading the consent form, be able to answer questions about the study and demonstrate understanding of the protocol;
  5. Be able to participate in regular follow-up visits.

Exclusion Criteria

  1. Severe chronic or acute disease: cancer, clinically significant congestive heart failure, chronic obstructive pulmonary disease (COPD), previous or new-onset diabetes, inflammatory state, serum creatinine >1.5 mg/dl , active liver disease, History of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) cardiovascular events (MI, PTCA, CABG, stroke), severe renal insufficiency, inflammatory bowel disease, persistent glucocorticoids Treatment; neurological diseases such as dementia, AD, PD, etc.; infectious diseases such as HIV, hepatitis, tuberculosis, etc.; severe autoimmune diseases;
  2. BMI<18.5 or BMI>30;
  3. Persistent alcohol or drug abuse;
  4. Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);
  5. Hypersensitivity to metformin or any component of the preparation;
  6. Have taken metformin, low-dose aspirin, acarbose, vitamin C in the recent (3 months);
  7. Unable to provide informed consent;
  8. Other circumstances in which the researcher believes that the physical factors of the participants may adversely affect the research process or results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin hydrochloride
1000 mg/day Metformin hydrochloride extended-release tablets
Drug: Metformin Hydrochloride tablet
Extended release oral tablets, 1000 mg/day, single dose
Other Names:
  • Metformin
Placebo Comparator: Placebo group
1000 mg/day placebo
Drug: Placebo
Oral tablets, 1000 mg/day, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline - 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.
Time Frame: 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.
Baseline - 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Merck Serono Co., Ltd., China
Institute of Zoology, Chinese Academy of Sciences
Beijing Institute of Genomics, Chinese Academy of Sciences

Investigators

  • Study Chair: Guoguang Zhao, professor, Xuanwu Hospital, Beijing
  • Principal Investigator: Guoguang Zhao, professor, Xuanwu Hospital, Beijing
  • Study Director: Jing Li, professor, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lijingxw

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Metformin Hydrochloride tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe