RecruitingPhase 2NCT06459310

Pilot Study on Evaluating the Geroprotective Effect of Metformin

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

130 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

DRUGMetformin Hydrochloride tablet

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

DRUGPlacebo

Oral tablets, 1000 mg/day, single dose


Locations(1)

Xuanwu Hospital Capital Medical University

Beijing, China

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NCT06459310


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