NCT05749874

Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

Assess the Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus Among Individuals With High Cardiometabolic Risk

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,024 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine on preventing cardiovascular disease and diabetes mellitus among individuals with high cardiometabolic risk in China.

Detailed description

The trial aims to evaluate the efficacy and safety of berberine treatment for individuals with high cardiometabolic risk. Potential eligible patients will be recruited from about 100 medical centers in China. After a 4-to-6-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 500mg twice a day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be followed up at month 3 and month 6, and once every 3 months thereafter, and be followed up for 3 years.

Conditions

• PreDiabetes
• Abdominal Obesity
• Hypertension
• Dyslipidemias
• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Berberine plus lifestyle intervention	berberine hydrochloride 500mg twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.
BEHAVIORAL	Placebo plus lifestyle intervention	Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.

Timeline

• Start date: 2023-10-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-03-01
• Last updated: 2025-12-31

Locations

1 site across 1 country: China