Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,200
- 试验地点
- 1
- 主要终点
- Rate of composite cardiometabolic endpoints
研究概览
简要总结
The metabolic syndrome population is at high-risk of cardiovascular diseases and diabetes. How to effectively control the risk factors of this population is the key to primary prevention of cardiovascular diseases and diabetes in China. This study aims to explore the efficacy and safety of an intervention strategy with berberine that can effectively treat a variety of risk factors (hyperglycemia, dyslipidemia, hypertension).
详细描述
Metabolic syndrome (MS) is a condition with multiple abnormal metabolic components, including obesity, dysglycemia, dyslipidemia and hypertension. The components of metabolic syndrome are major risk factors for cardiovascular disease and diabetes. Cardiovascular disease (CVD) is the primary cause of death and disease burden in China. This study aims to explore an intervention drug that can effectively control a variety of risk factors (hyperglycemia, dyslipidemia, hypertension), so as to improve the effectiveness and practical feasibility of primary prevention. Berberine is a drug with multiple function. Basic studies and previous clinical studies suggest that it has definite regulatory effects on blood glucose, lipid levels and blood pressure with few adverse reactions. This study selected pleiotropic Berberine as a means of intervention. It would provide new thought and high-level evidence for the primary prevention of cardiovascular disease and diabetes in Chinese population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with metabolic syndrome aged 40-75 years old.
- •Metabolic syndrome was defined according to the Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults (revised edition 2016). Subjects will be diagnosed with metabolic syndrome when meeting three or more of the following items: 1, central obesity and/or abdominal obesity (waist circumference ≥90cm for men and ≥ 85cm for women); 2, hyperglycemia (fasting blood glucose ≥6.10 mmol/L or two-hour blood glucose ≥7.80 mmol/L in glucose tolerance test); 3, hypertension: blood pressure ≥130/85 mmHg and/or diagnosed hypertension under treatment; 4, fasting triglyceride ≥1.7 mmol/L (150mg/dl); 5, fasting HDL cholesterol<1.0 mmol/L.
排除标准
- •Previously diagnosed diabetes.
- •Baseline LDL cholesterol≥130mg/dl (3.4mmol/L).
- •Baseline triglyceride≥500mg/dl (5.6mmol/L).
- •Baseline blood pressure ≥140/90 mmHg (twice not on the same day).
- •Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine/aspartate aminotransferase levels >3 times the upper limit of the reference range at the screening visit.
- •Renal dysfunction (glomerular filtration rate<45ml/min)
- •Patients ventilated by ventilator.
- •Hypersensitivity to berberine.
- •Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).
- •Severe chronic gastrointestinal disease.
- •Severe psychiatric illness.
- •Cancer requiring treatment in past 5 years.
- •Women who are pregnant or breastfeeding .
- •Participation in another clinical trial within the past 30 days .
- •Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
研究组 & 干预措施
Placebo Group
Placebo plus healthy lifestyle intervention. Placebo with same appearance of berberine tablet will be orally taken twice daily and maintained until the last subject completes 3-year intervention.
干预措施: Healthy lifestyle intervention (Behavioral)
Berberine Group
Berberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention.
干预措施: Berberine (Drug)
Berberine Group
Berberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention.
干预措施: Healthy lifestyle intervention (Behavioral)
结局指标
主要结局
Rate of composite cardiometabolic endpoints
时间窗: three year
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.
次要结局
- Rate of composite endpoints of cardiovascular diseases 1(three year)
- Rate of all-cause mortality(three year)
- Rates of each component of the composite end point(three year)
- Rate of composite end point of cardiovascular disease 2(three year)
- Rate of newly diagnosed prediabetes(three year)
- Rate of newly diagnosed hypertension(three year)
- Rate of newly diagnosed malignancy(three year)
- Concentrations of serum lipid parameters(three year)
- Changes of abdominal circumference(three year)
- Changes of waist-hip ratio(three year)
- Changes of body mass index(three year)
研究者
Tang Yida
Chief-Cardiologist and Director
Peking University Third Hospital