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Intervention Study on the Improvement of Endothelial Dilation Function by Metformin Combined with Folic Acid, Vitamin B6, and B12 in a High-Risk Cardiovascular Population

Intervention Study on the Improvement of Endothelial Dilation Function by Metformin Combined with Folic Acid, Vitamin B6, and B12 in a High-Risk Cardiovascular Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122137
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-04-09
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Control group:Take a placebo daily (2 tablets per dose, twice daily)
Vitamin group:Take vitamins (folic acid, vitamin B6 and B12) daily and a placebo (1 tablet of vitamins and 1 tablet of placebo each time, twice a day)
Metformin group:Take metformin and a placebo daily (1 tablet of metformin and 1 tablet of placebo per dose, twice daily)
Metformin combined with vitamins group:Take metformin plus vitamins (folic acid, vitamin B6, and B12) daily (1 tablet of metformin and 1 tablet of vitamins per dose, twice daily).

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 40 - 65 years old; 2. Gender: No restrictions; 3. Patients with carotid intima-media thickness (cIMT) of 1.0 mm <= cIMT < 2.0 mm as determined by carotid artery ultrasound examination; 4. High-risk cardiovascular population; such as abnormal blood lipids, hypertension, smoking, obesity, family history of premature cardiovascular disease, etc.; 5. Have basic reading ability, have a smart phone, and be able to use social software such as WeChat; 6. Agree to participate and be able to cooperate with the research and complete the follow-up, provide the signed informed consent form of the research subject.

Exclusion criteria

Exclusion criteria: 1. Subjects with a history or current diagnosis of any tumor; 2. Subjects currently pregnant, those who have been pregnant or lactating in the past two years, or those planning to become pregnant within the next year; 3. Subjects diagnosed with AIDS; 4. Subjects with unstable angina pectoris, those who have experienced acute myocardial infarction within the past six months, or those who have recently undergone surgical intervention; 5. Subjects who are unable to undergo and complete the intervention treatment due to mental disorders, physical disabilities, other medical conditions or physical problems; 6. Subjects who are currently, recently or plan to participate in other clinical trials, weight loss programs or other intervention studies; 7. Subjects currently using weight loss drugs; 8. Subjects using any vitamins or medications that affect homocysteine levels, or subjects currently following the clinical prescribed diet; 9. Subjects with severe cardiovascular diseases, diabetes, liver failure, or life-threatening diseases with a prognosis of less than five years; 10. Subjects that researchers consider to be obstacles to participation or may affect compliance, any other situation that the researchers deem relevant.

Design outcomes

Primary

MeasureTime frame
Brachial artery endothelial dilation function;

Secondary

MeasureTime frame
Weight;Height;Waist circumference;Hip circumference;Body fat percentage;Blood pressure;Oxidative stress level;SAM level;SAH level;tHCY level;Routine blood indexes;Inflammatory factors;Vitamin B12;Lactic Acid;

Countries

China

Contacts

Public ContactXiao Yunjun

The Seventh Affiliated Hospital, Sun Yat-sen University(Shenzhen)

xyjszcdc@163.com+86 755 8120 6999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026