Metformin, Aging
Conditions
Keywords
aging intervention, metformin, aging biomarker, multi-omics, middle-aged and elderly people, molecular clocks, biological age
Brief 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.
Detailed description
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.
Interventions
Extended release oral tablets, 1000 mg/day, single dose
DRUGPlacebo
Oral tablets, 1000 mg/day, single dose
Sponsors
Institute of Zoology, Chinese Academy of Sciences
Beijing Institute of Genomics, Chinese Academy of Sciences
Merck Serono Co., Ltd., China
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite the efficacy of metformin in intervening aging | Baseline - 12 month | 1. Metformin delay aging related sensitive indicators (2), such as SA\*, ancient virus \*. 2. Metformin inhibits markers of inflammation in the body (4), such as C1 protein \*, CRP, CXCL9, TNFa. 3. Metformin improved immune cell-related indicators (10\*), such as T1/T2/L gene expression. 4. Metformin improves metabolism-related indexes (4), such as metabolic secretion factors APOX1\* and APOX2\*. 5. Age-related indicators have been published (5), such as telomere length, DNA methylation age, hormone levels, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging. | Baseline - 12 month | 1. Aging atlas-R, PBMC RNA profiling, \>5% DEGs. 2. Aging atlas-P, proteomic profiling, \>5% DEPs. 3. Aging atlas-M, metabolic profiling, \>5% metabolites. 4. Aging atlas-B, metagenomic profiling, \>5% microbiotas. 5. Reduce human biological age complex parameters. |
Countries
China
Contacts
Primary ContactLingling Geng
Backup ContactGele Qu
Outcome results
None listed