Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

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.

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 diseaseExclusion Criteria:Patients with established atherosclerotic cardiovascular disease, including coronary heart disease, ischemic stroke, and peripheral atherosclerotic diseasesPatients diagnosed with diabetes or taking oral glucose-lowering drugsPatients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiencyPatients taking berberine or drug containing berberine in the past 1 monthPatients with any adverse reaction to berberinePatients 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 lossPatients with active liver diseases, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) > 3 times upper limit of normalEstimated glomerular filtration rate (eGFR) < 45 ml/(min×1.73m2)Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trialPatients with malignant tumors, or other serious diseases with life expectancy of less than 3 yearsPatients with mental disorders, cognitive disorders, or other serious diseases that could affect study participationPatients who participated or have been participating other trials during the last 3 monthsAny other conditions that may hinder the compliance to the study intervention or follow-up visit