Pilot Study on Evaluating the Geroprotective Effect of Metformin

NCT06459310 | Recruiting Phase 2

• 1 other identifier: lijingxw
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Metformin; Aging

Keywords

aging intervention; metformin; aging biomarker; multi-omics; middle-aged and elderly people; molecular clocks; biological age

Outcome Measures

Primary Outcomes (1)

• Composite the efficacy of metformin in intervening aging

  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 Outcomes (1)

• Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.

  Baseline - 12 month

Study Arms (2)

Metformin hydrochloride

EXPERIMENTAL

1000 mg/day Metformin hydrochloride extended-release tablets

Drug: Metformin Hydrochloride tablet

Placebo group

PLACEBO COMPARATOR

1000 mg/day placebo

Drug: Placebo

Interventions

Metformin Hydrochloride tablet DRUG

Extended release oral tablets, 1000 mg/day, single dose

Also known as: Metformin

Metformin hydrochloride

Placebo DRUG

Oral tablets, 1000 mg/day, single dose

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• BMI\<18.5 or BMI\>30;
• Persistent alcohol or drug abuse;
• Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);
• Hypersensitivity to metformin or any component of the preparation;
• Have taken metformin, low-dose aspirin, acarbose, vitamin C in the recent (3 months);
• Unable to provide informed consent;
• Other circumstances in which the researcher believes that the physical factors of the participants may adversely affect the research process or results.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Institute of Zoology, Chinese Academy of Sciences: collaborator
• Beijing Institute of Genomics, Chinese Academy of Sciences: collaborator
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

Related Publications (15)

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MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Guoguang Zhao, professor

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Guoguang Zhao, professor

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Jing Li, professor

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Lingling Geng

CONTACT

18510932169; gengll@xwhosp.org

Gele Qu

CONTACT

13601310067; qugeyue@xwhosp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)