Ancient chinese herb berberine tested to stop heart disease and diabetes in its tracks
NCT ID NCT05749874
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large, phase 4 trial is testing whether berberine, a natural compound, can prevent heart disease and diabetes in over 2,000 high-risk adults in China. Participants take berberine or a placebo twice daily, plus receive lifestyle advice. The study tracks blood sugar and heart health over time to see if berberine reduces the risk of developing these conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- berberine hydrochloride
- What this could lead to
- If it works, this could point toward a simple, affordable supplement to help prevent heart disease and diabetes in people at high risk.
- What could go wrong
- This is a single large trial in China, so results may not apply to other populations. Berberine can cause digestive side effects and may interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
2,024 people
The number who actually took part.
- Started
-
Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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