Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus (NCT05749874) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus
China2,024 participantsStarted 2023-10-31
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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 …
What they're measuring
1
The distribution of glycemic status at 1 year after randomization
Timeframe: Intervention Period: 1 year
Trial details
NCT IDNCT05749874
SponsorChina National Center for Cardiovascular Diseases