Pilot Study on Evaluating the Geroprotective Effect of Metformin
NCT ID: NCT06459310
Last Updated: 2025-03-21
Study Results
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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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2024-06-30
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Metformin hydrochloride
1000 mg/day Metformin hydrochloride extended-release tablets
Metformin Hydrochloride tablet
Extended release oral tablets, 1000 mg/day, single dose
Placebo group
1000 mg/day placebo
Placebo
Oral tablets, 1000 mg/day, single dose
Interventions
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Metformin Hydrochloride tablet
Extended release oral tablets, 1000 mg/day, single dose
Placebo
Oral tablets, 1000 mg/day, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
MALE
Yes
Sponsors
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Institute of Zoology, Chinese Academy of Sciences
OTHER_GOV
Beijing Institute of Genomics, Chinese Academy of Sciences
OTHER_GOV
Merck Serono Co., Ltd., China
INDUSTRY
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Chai M, Jiang M, Vergnes L, Fu X, de Barros SC, Doan NB, Huang W, Chu J, Jiao J, Herschman H, Crooks GM, Reue K, Huang J. Stimulation of Hair Growth by Small Molecules that Activate Autophagy. Cell Rep. 2019 Jun 18;27(12):3413-3421.e3. doi: 10.1016/j.celrep.2019.05.070.
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.
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.
TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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lijingxw
Identifier Type: -
Identifier Source: org_study_id
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