Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)

Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial

The metabolic syndrome population is at high-risk of cardiovascular diseases and diabetes. How to effectively control the risk factors of this population is the key to primary prevention of cardiovascular diseases and diabetes in China. This study aims to explore the efficacy and safety of an intervention strategy with berberine that can effectively treat a variety of risk factors (hyperglycemia, dyslipidemia, hypertension).

Metabolic syndrome (MS) is a condition with multiple abnormal metabolic components, including obesity, dysglycemia, dyslipidemia and hypertension. The components of metabolic syndrome are major risk factors for cardiovascular disease and diabetes. Cardiovascular disease (CVD) is the primary cause of death and disease burden in China. This study aims to explore an intervention drug that can effectively control a variety of risk factors (hyperglycemia, dyslipidemia, hypertension), so as to improve the effectiveness and practical feasibility of primary prevention. Berberine is a drug with multiple function. Basic studies and previous clinical studies suggest that it has definite regulatory effects on blood glucose, lipid levels and blood pressure with few adverse reactions. This study selected pleiotropic Berberine as a means of intervention. It would provide new thought and high-level evidence for the primary prevention of cardiovascular disease and diabetes in Chinese population.

Inclusion Criteria:

• Patients diagnosed with metabolic syndrome aged 40-75 years old.
• Metabolic syndrome was defined according to the Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults (revised edition 2016). Subjects will be diagnosed with metabolic syndrome when meeting three or more of the following items: 1, central obesity and/or abdominal obesity (waist circumference ≥90cm for men and ≥ 85cm for women); 2, hyperglycemia (fasting blood glucose ≥6.10 mmol/L or two-hour blood glucose ≥7.80 mmol/L in glucose tolerance test); 3, hypertension: blood pressure ≥130/85 mmHg and/or diagnosed hypertension under treatment; 4, fasting triglyceride ≥1.7 mmol/L (150mg/dl); 5, fasting HDL cholesterol<1.0 mmol/L.

Exclusion Criteria:

• Previously diagnosed diabetes.
• Baseline LDL cholesterol≥130mg/dl (3.4mmol/L).
• Baseline triglyceride≥500mg/dl (5.6mmol/L).
• Baseline blood pressure ≥140/90 mmHg (twice not on the same day).
• Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine/aspartate aminotransferase levels >3 times the upper limit of the reference range at the screening visit.
• Renal dysfunction (glomerular filtration rate<45ml/min)
• Patients ventilated by ventilator.
• Hypersensitivity to berberine.
• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).
• Severe chronic gastrointestinal disease.
• Severe psychiatric illness.
• Cancer requiring treatment in past 5 years.
• Women who are pregnant or breastfeeding .
• Participation in another clinical trial within the past 30 days .
• Other significant disease that in the Investigator's opinion would exclude the subject from the trial.