Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

Inclusion Criteria:

• Participants aged ≥45 years (male) or 55 years (female)
• Participants with abdominal obesity (i.e., waist circumference ≥85 cm in female orwaist 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) currentsmoker, (c) HDL-C<1mmol/L and/or TG≥1.7mmol/L, (d) family history of prematurecoronary heart disease

Exclusion Criteria:

• Patients with established atherosclerotic cardiovascular disease, including coronaryheart 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 forweight loss
• Patients with active liver diseases, or alanine aminotransferase (ALT) / aspartateaminotransferase (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 thetrial
• Patients with malignant tumors, or other serious diseases with life expectancy of lessthan 3 years
• Patients with mental disorders, cognitive disorders, or other serious diseases thatcould affect study participation
• Patients who participated or have been participating other trials during the last 3months
• Any other conditions that may hinder the compliance to the study intervention orfollow-up visit