Pilot Study on Evaluating the Geroprotective Effect of Metformin

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Metformin Hydrochloride tablet
  Extended release oral tablets, 1000 mg/day, single dose
• Препарат Placebo
  Oral tablets, 1000 mg/day, single dose

Первичные конечные точки

• Composite the efficacy of metformin in intervening aging [Срок оценки: Baseline - 12 month]

Вторичные конечные точки (1)

• Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging. [Срок оценки: Baseline - 12 month]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Xuanwu Hospital Capital Medical University — Пекин

Публикации

• 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. PMID 23540700
• 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. PMID 31216464
• 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. PMID 25456737
• 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. PMID 9428832
• 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. PMID 22540912
• 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. PMID 24080598
• 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. PMID 33443781
• 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. PMID 32333835

Идентификаторы

NCT: NCT06459310 · lijingxw

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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