About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
Metformin Hydrochloride tablet
DrugExtended release oral tablets, 1000 mg/day, single dose
Placebo
DrugOral tablets, 1000 mg/day, single dose
Treatment groups
Trial outcomes
Primary outcomes
Composite the efficacy of metformin in intervening aging
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 outcomes
Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xuanwu Hospital, Beijing
Lead sponsor
Institute of Zoology, Chinese Academy of Sciences
Collaborator
Beijing Institute of Genomics, Chinese Academy of Sciences
Collaborator
Merck Serono Co., Ltd., China
Collaborator