Active, not recruiting
Phase 4
Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus
Condition(s) studied
PreDiabetesAbdominal ObesityHypertensionDyslipidemiasAtherosclerotic Cardiovascular Disease
Investigational drug(s) / intervention(s)
Berberine plus lifestyle interventionPlacebo plus lifestyle intervention
Berberine plus lifestyle intervention: berberine hydrochloride 500mg twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.
Placebo plus lifestyle intervention: Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.
Study 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.
Eligibility
Inclusion Criteria:
* Participants aged ≥40 years old
* Participants with prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%
* Participants with body mass index\>25kg/m2, or abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
* Participants with established atherosclerosis cardiovascular diseases (ASCVD), or with at least two cardiovascular risk factors: (a) hypertension (b) aged ≥45(male) / 55 (female), (c) current smoker, (d) HDL-C\<1mmol/L or TG≥2.3mmol/L
* Participants with established ASCVD required LDL-C≤70 mg/dL (1.8mmol/L) for participants with ASCVD or receiving optimized LDL-C-lowering therapy (at least moderate-intensity statin therapy, unless contraindicated or intolerant)
Exclusion Criteria:
* Participants with FPG≥7.0 mmol/L, diagnosed with diabetes or taking oral glucose-lowering drugs
* Participants diagnosed with acute coronary syndrome, stroke, transient ischemic attack, or undergoing cardiac surgery or cardiac intervention (i.e., implantation of cardiac closure devices, cardiac resynchronization therapy, or catheter ablation), percutaneous coronary intervention or valvuloplasty/other cardiac valve repair or implantation surgery within the 3 months before randomization
* Participants who plan to perform coronary and/or non coronary revascularization surgery, or cardiac surgery within 6 months after randomization
* Participants diagnosed with heart failure or left ventricular ejection fraction\<40%, severe cardiac valvular disease, cardiomyopathy, congenital heart disease
* Conditions known to interfere with the accuracy of HbA1c measurement, including rheumatoid arthritis, hemolytic anemia, aplastic anemia, hemoglobinopathies, splenomegaly, splenectomy, vitamin B12 deficiency, alcoholism, long-term high-dose aspirin use, or chronic use of anesthetics or hydroxyurea
* Recipients of major organ transplants (e.g., lung, liver, heart, bone marrow, kidneys, etc.)
* Participants diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Participants taking berberine or drug containing berberine in the past 1 month
* Participants with any adverse reaction to berberine
* Participants with severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
* Participants who plan to have weight loss surgery, plan to take or currently taking drugs for weight loss
* Participants 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
* Participants with malignant tumors, or other serious diseases with life expectancy of less than 3 years
* Participants with mental disorders, cognitive disorders, or other serious diseases that could affect study participation
* Participants 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
Primary outcome measure(s)
- The distribution of glycemic status at 1 year after randomization — Intervention Period: 1 year
Categorized as normal glucose metabolism, prediabetes, and diabetes
Trial sites (1)
| Facility | City | Region | Status |
| Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases |
Beijing |
China |
|
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