Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Feb 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how a natural substance called berberine might help prevent serious health issues like heart disease and diabetes in people at high risk. The study will involve adults in China who are dealing with conditions like prediabetes, obesity, high blood pressure, or unhealthy cholesterol levels. To participate, you need to be at least 45 years old if you're a man, or 55 years old if you're a woman, and have certain measurements like a larger waist size and specific blood sugar levels.

If you qualify and choose to join, you'll be part of a double-blinded study, meaning neither you nor the researchers will know if you're receiving the berberine or a placebo (a non-active substance). This helps ensure the results are unbiased. Participants will be monitored throughout the trial, and it's important to note that those with certain medical conditions, such as established heart disease or severe intestinal disorders, will not be eligible. Overall, this study aims to gather more information on whether berberine can be an effective way to improve health for those at risk of cardiovascular problems and diabetes.

Gender

ALL

Eligibility 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 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