Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus
NCT ID: NCT05749874
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
2024 participants
INTERVENTIONAL
2023-10-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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berberine group
Berberine hydrochloride 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 group
Placebo plus lifestyle intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Jing Li, PhD
Role: PRINCIPAL_INVESTIGATOR
National Center for Cardiovascular Diseases
Haibo Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
National Center for Cardiovascular Diseases
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Beijing, , China
Countries
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References
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Kong WJ, Vernieri C, Foiani M, Jiang JD. Berberine in the treatment of metabolism-related chronic diseases: A drug cloud (dCloud) effect to target multifactorial disorders. Pharmacol Ther. 2020 May;209:107496. doi: 10.1016/j.pharmthera.2020.107496. Epub 2020 Jan 27.
Kong W, Wei J, Abidi P, Lin M, Inaba S, Li C, Wang Y, Wang Z, Si S, Pan H, Wang S, Wu J, Wang Y, Li Z, Liu J, Jiang JD. Berberine is a novel cholesterol-lowering drug working through a unique mechanism distinct from statins. Nat Med. 2004 Dec;10(12):1344-51. doi: 10.1038/nm1135. Epub 2004 Nov 7.
Other Identifiers
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2021-CXGC04-1
Identifier Type: -
Identifier Source: org_study_id