Pilot Study on Evaluating the Geroprotective Effect of Metformin

NCT ID: NCT06459310

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2028-07-31

Brief Summary

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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

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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.

Conditions

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Metformin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metformin hydrochloride

1000 mg/day Metformin hydrochloride extended-release tablets

Group Type EXPERIMENTAL

Metformin Hydrochloride tablet

Intervention Type DRUG

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

Placebo group

1000 mg/day placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets, 1000 mg/day, single dose

Interventions

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Metformin Hydrochloride tablet

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

Intervention Type DRUG

Placebo

Oral tablets, 1000 mg/day, single dose

Intervention Type DRUG

Other Intervention Names

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Metformin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Zoology, Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Beijing Institute of Genomics, Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Merck Serono Co., Ltd., China

INDUSTRY

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoguang Zhao, professor

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Guoguang Zhao, professor

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Jing Li, professor

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingling Geng

Role: CONTACT

18510932169

Gele Qu

Role: CONTACT

13601310067

Facility Contacts

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Ming Yi

Role: primary

13269087337

Liyun Zhao

Role: backup

17801137417

References

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de Villartay JP, Rouger P, Muller JY, Salmon C. HLA antigens on peripheral red blood cells: analysis by flow cytofluorometry using monoclonal antibodies. Tissue Antigens. 1985 Jul;26(1):12-9. doi: 10.1111/j.1399-0039.1985.tb00929.x.

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Foretz M, Guigas B, Bertrand L, Pollak M, Viollet B. Metformin: from mechanisms of action to therapies. Cell Metab. 2014 Dec 2;20(6):953-66. doi: 10.1016/j.cmet.2014.09.018. Epub 2014 Oct 30.

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Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997 Dec;103(6):491-7. doi: 10.1016/s0002-9343(97)00254-4.

Reference Type BACKGROUND
PMID: 9428832 (View on PubMed)

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Reference Type BACKGROUND
PMID: 22540912 (View on PubMed)

Cabreiro F, Au C, Leung KY, Vergara-Irigaray N, Cocheme HM, Noori T, Weinkove D, Schuster E, Greene ND, Gems D. Metformin retards aging in C. elegans by altering microbial folate and methionine metabolism. Cell. 2013 Mar 28;153(1):228-39. doi: 10.1016/j.cell.2013.02.035.

Reference Type BACKGROUND
PMID: 23540700 (View on PubMed)

Gronich N, Rennert G. Beyond aspirin-cancer prevention with statins, metformin and bisphosphonates. Nat Rev Clin Oncol. 2013 Nov;10(11):625-42. doi: 10.1038/nrclinonc.2013.169. Epub 2013 Oct 1.

Reference Type BACKGROUND
PMID: 24080598 (View on PubMed)

Kodali M, Attaluri S, Madhu LN, Shuai B, Upadhya R, Gonzalez JJ, Rao X, Shetty AK. Metformin treatment in late middle age improves cognitive function with alleviation of microglial activation and enhancement of autophagy in the hippocampus. Aging Cell. 2021 Feb;20(2):e13277. doi: 10.1111/acel.13277. Epub 2021 Jan 14.

Reference Type BACKGROUND
PMID: 33443781 (View on PubMed)

Kulkarni AS, Gubbi S, Barzilai N. Benefits of Metformin in Attenuating the Hallmarks of Aging. Cell Metab. 2020 Jul 7;32(1):15-30. doi: 10.1016/j.cmet.2020.04.001. Epub 2020 Apr 24.

Reference Type BACKGROUND
PMID: 32333835 (View on PubMed)

Li C, Mu N, Gu C, Liu M, Yang Z, Yin Y, Chen M, Wang Y, Han Y, Yu L, Ma H. Metformin mediates cardioprotection against aging-induced ischemic necroptosis. Aging Cell. 2020 Feb;19(2):e13096. doi: 10.1111/acel.13096. Epub 2020 Jan 14.

Reference Type BACKGROUND
PMID: 31944526 (View on PubMed)

Williams-Herman D, Johnson J, Teng R, Golm G, Kaufman KD, Goldstein BJ, Amatruda JM. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):442-51. doi: 10.1111/j.1463-1326.2010.01204.x.

Reference Type BACKGROUND
PMID: 20415693 (View on PubMed)

Neumann B, Baror R, Zhao C, Segel M, Dietmann S, Rawji KS, Foerster S, McClain CR, Chalut K, van Wijngaarden P, Franklin RJM. Metformin Restores CNS Remyelination Capacity by Rejuvenating Aged Stem Cells. Cell Stem Cell. 2019 Oct 3;25(4):473-485.e8. doi: 10.1016/j.stem.2019.08.015.

Reference Type BACKGROUND
PMID: 31585093 (View on PubMed)

Martin-Montalvo A, Mercken EM, Mitchell SJ, Palacios HH, Mote PL, Scheibye-Knudsen M, Gomes AP, Ward TM, Minor RK, Blouin MJ, Schwab M, Pollak M, Zhang Y, Yu Y, Becker KG, Bohr VA, Ingram DK, Sinclair DA, Wolf NS, Spindler SR, Bernier M, de Cabo R. Metformin improves healthspan and lifespan in mice. Nat Commun. 2013;4:2192. doi: 10.1038/ncomms3192.

Reference Type BACKGROUND
PMID: 23900241 (View on PubMed)

Ma T, Tian X, Zhang B, Li M, Wang Y, Yang C, Wu J, Wei X, Qu Q, Yu Y, Long S, Feng JW, Li C, Zhang C, Xie C, Wu Y, Xu Z, Chen J, Yu Y, Huang X, He Y, Yao L, Zhang L, Zhu M, Wang W, Wang ZC, Zhang M, Bao Y, Jia W, Lin SY, Ye Z, Piao HL, Deng X, Zhang CS, Lin SC. Low-dose metformin targets the lysosomal AMPK pathway through PEN2. Nature. 2022 Mar;603(7899):159-165. doi: 10.1038/s41586-022-04431-8. Epub 2022 Feb 23.

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Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. Hallmarks of aging: An expanding universe. Cell. 2023 Jan 19;186(2):243-278. doi: 10.1016/j.cell.2022.11.001. Epub 2023 Jan 3.

Reference Type BACKGROUND
PMID: 36599349 (View on PubMed)

Other Identifiers

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lijingxw

Identifier Type: -

Identifier Source: org_study_id

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