NCT05749874进行中（未招募）4 期
Assess the Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus Among Individuals With High Cardiometabolic Risk
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 2,024 人开始时间: 2023年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,024
- 试验地点
- 1
- 主要终点
- The distribution of glycemic status at 1 year after randomization
研究概览
简要总结
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.
详细描述
The trial aims to evaluate the efficacy and safety of berberine treatment for individuals with high cardiometabolic risk. Potential eligible patients will be recruited from about 100 medical centers in China. After a 4-to-6-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 500mg twice a day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be followed up at month 3 and month 6, and once every 3 months thereafter, and be followed up for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
berberine group
Experimental
Berberine hydrochloride plus lifestyle intervention
干预措施: Berberine plus lifestyle intervention (Drug)
placebo group
Placebo Comparator
Placebo plus lifestyle intervention
干预措施: Placebo plus lifestyle intervention (Behavioral)
结局指标
主要结局
The distribution of glycemic status at 1 year after randomization
时间窗: Intervention Period: 1 year
Categorized as normal glucose metabolism, prediabetes, and diabetes
次要结局
- Changes of glycemic-related parameters(Intervention Period: 1 year)
- Changes of lipid-related parameters(Intervention Period: 1 year)
- Change of inflammation-related marker(Intervention Period: 1 year)
- Normalization of glucose parameters(Intervention Period: 1 year)
- Time to newly diagnosed cancer(Entire follow-up period: 4 years)
- Change of physical examination measures(Intervention Period: 1 year)
- Changes of other parameters(Intervention Period: 1 year)
- Change of depressive symptoms(Intervention Period: 1 year)
- Time to first occurrence of composite endpoint of major cardiovascular event and diabetes(Entire follow-up period: 4 years)
- Time to new-onset diabetes(Entire follow-up period: 4 years)
- Exploratory biomarker analyses(Intervention Period: 1 year)
- Time to first occurrence of composite endpoint of major cardiovascular event 1(Entire follow-up period: 4 years)
- Time to first occurrence of composite endpoint of major cardiovascular event 2(Entire follow-up period: 4 years)
研究者
研究点 (1)
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