Clinical trial NCT06459310: Pilot Study on Evaluating the Geroprotective Effect of Metformin
Official title: A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metformin
Aging
Keywords: aging intervention
metformin
aging biomarker
multi-omics
middle-aged and elderly people
molecular clocks
biological age
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Institute of Zoology, Chinese Academy of Sciences
name: Beijing Institute of Genomics, Chinese Academy of Sciences
name: Merck Serono Co., Ltd., China
First posted: 2024-06-14
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Composite the efficacy of metformin in intervening aging
timeFrame: Baseline - 12 month
Secondary outcomes:
measure: Composite Through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.
timeFrame: Baseline - 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Guoguang Zhao, professor
role: STUDY_CHAIR
affiliation: Xuanwu Hospital, Beijing
name: Guoguang Zhao, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Jing Li, professor
role: STUDY_DIRECTOR
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