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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
5,200
The tablet of berberine and placebo are both coated with white sugar and had the same appearance. Berberine tablet will be orally taken with a dose of 500mg twice daily
Healthy lifestyle intervention will be launched according to the "Chinese guidelines on prevention of cardiovascular and metabolic diseases by Chinese Preventive Medical Association in 2019", including health lectures, health information promotion, health manual and so on.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Rate of composite cardiometabolic endpoints
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.
Time frame: three year
Rate of composite endpoints of cardiovascular diseases 1
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke.
Time frame: three year
Rate of composite end point of cardiovascular disease 2
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, successful resuscitation of cardiac arrest, heart failure, arterial revascularization.
Time frame: three year
Rates of each component of the composite end point
Each component of the composite end point
Time frame: three year
Rate of all-cause mortality
Death due to all causes.
Time frame: three year
Rate of newly diagnosed prediabetes
Prediabetes including impaired fasting glucose and abnormal glucose tolerance.
Time frame: three year
Rate of newly diagnosed hypertension
Hypertension is defined as blood pressure≥140/90 millimeters of mercury measured twice at not same day.
Time frame: three year
Rate of newly diagnosed malignancy
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Newly diagnosed malignancy.
Time frame: three year
Concentrations of serum lipid parameters
Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, Lp(a).
Time frame: three year
Changes of abdominal circumference
Measurement of abdominal circumference in centimeter
Time frame: three year
Changes of waist-hip ratio
Measurement of waist-hip ratio
Time frame: three year
Changes of body mass index
Measurement of body mass index in kg/m\^2
Time frame: three year