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NCT Number: NCT06459310

Pilot Study on Evaluating the Geroprotective Effect of Metformin

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Xuanwu Hospital Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Guanghui Liu, professor

SUB_INVESTIGATOR

Guoguang Zhao, professor

PRINCIPAL_INVESTIGATOR

Jing Li, professor

SUB_INVESTIGATOR

Liyun Zhao

CONTACT

[email protected]

17801137417

Ming Yi

CONTACT

[email protected]

13269087337

Weiqi Zhang, professor

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Metformin Hydrochloride tablet

Drug

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

Other names: Metformin

Placebo

Drug

Oral tablets, 1000 mg/day, single dose

Primary outcomes

  1. Composite the efficacy of metformin in intervening aging

    Time frame: Baseline - 12 month

    • Metformin delay aging related sensitive indicators (2), such as SA*, ancient virus *.
    • Metformin inhibits markers of inflammation in the body (4), such as C1 protein *, CRP, CXCL9, TNFa.
    • Metformin improved immune cell-related indicators (10*), such as T1/T2/L gene expression.
    • Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1* and APOX2*.
    • Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc.

Secondary outcomes

  1. 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

    • Aging atlas-R, PBMC RNA profiling, >5% DEGs.
    • Aging atlas-P, proteomic profiling, >5% DEPs.
    • Aging atlas-M, metabolic profiling, >5% metabolites.
    • Aging atlas-B, metagenomic profiling, >5% microbiotas.
    • Reduce human biological age complex parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Gele Qu

CONTACT

[email protected]

13601310067

Lingling Geng

CONTACT

[email protected]

18510932169

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AGE-M

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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