Evaluating the effects of metformin on aging in older men
A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
This study is testing if the diabetes drug metformin can help older men slow down the aging process.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06459310 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the effectiveness of oral metformin in slowing the aging process among middle-aged and elderly males. Participants will be divided into two groups, receiving either metformin or a placebo, with treatment administered once daily for one year. The study will also identify sensitive biomarkers of aging and provide insights for future pharmaceutical interventions targeting aging. The research is designed to enhance our understanding of aging and the potential role of metformin in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males aged 55 to 65 who can comply with study protocols.
Not a fit: Patients with severe chronic diseases or significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new interventions that slow down the aging process in older adults.
How similar studies have performed: While the approach of using metformin for aging is novel, there have been preliminary studies suggesting potential benefits, indicating a growing interest in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Xuanwu Hospital Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Guoguang Zhao, professor — Xuanwu Hospital, Beijing
- Study coordinator: Lingling Geng
- Email: gengll@xwhosp.org
- Phone: 18510932169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.