Aging Clinical Trial
— AGE-MOfficial title:
A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | July 31, 2028 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Beijing Institute of Genomics, Chinese Academy of Sciences, Institute of Zoology, Chinese Academy of Sciences, Merck Serono Co., Ltd., China |
China,
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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. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite the efficacy of metformin in intervening aging | Metformin delay aging related sensitive indicators (2), such as SA*, ancient virus *.
Metformin inhibits markers of inflammation in the body (4), such as C1 protein *, CRP, CXCL9, TNFa. Metformin improved immune cell-related indicators (10*), such as T1/T2/L gene expression. Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1* and APOX2*. Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc. |
Baseline - 12 month | |
Secondary | Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging. | Aging atlas-R, PBMC RNA profiling, >5% DEGs.
Aging atlas-P, proteomic profiling, >5% DEPs. Aging atlas-M, metabolic profiling, >5% metabolites. Aging atlas-B, metagenomic profiling, >5% microbiotas. Reduce human biological age complex parameters. |
Baseline - 12 month |
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