Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases

Criteria

Inclusion Criteria:

• Participants aged ≥45 years (male) or 55 years (female)

• Participants with abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)

• Participants with prediabetes, defined as: (a) impaired fasting glucose (IFG) (i.e., 6.1 mmol/L≤FPG<7.0 mmol/L), or (b) impaired glucose tolerance (IGT) (i.e., 7.8mmol/L≤2hPG<11.1 mmol/L)

• Participants who meet at least two of four criteria: (a) hypertension, (b) current smoker, (c) HDL-C<1mmol/L and/or TG≥1.7mmol/L, (d) family history of premature death of coronary heart disease

Exclusion Criteria:

• Patients with established atherosclerotic cardiovascular disease, including coronary heart disease, ischemic stroke, and peripheral atherosclerotic diseases

• Patients diagnosed with diabetes or taking oral glucose-lowering drugs

• Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Patients taking berberine or drug containing berberine in the past 1 month

• Patients with any adverse reaction to berberine

• Patients with severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)

• Patients who plan to have weight loss surgery, or are currently taking drugs for weight loss

• Patients with active liver diseases, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) > 3 times upper limit of normal

• Estimated glomerular filtration rate (eGFR) < 45 ml/(min×1.73m2)

• Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial

• Patients with malignant tumors, or other serious diseases with life expectancy of less than 3 years

• Patients with mental disorders, cognitive disorders, or other serious diseases that could affect study participation

• Patients who participated or have been participating other trials during the last 3 months

• Any other conditions that may hinder the compliance to the study intervention or follow-up visit