Metabolic Syndrome
Conditions
Keywords
Berberine, Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Primary Prevention
Brief summary
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).
Detailed description
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.
Interventions
DRUGBerberine
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
BEHAVIORALHealthy lifestyle intervention
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.
Sponsors
Chinese Society of Cardiology
Tang Yida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite cardiometabolic endpoints | three year | The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite end point of cardiovascular disease 2 | three year | The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, successful resuscitation of cardiac arrest, heart failure, arterial revascularization. |
| Rates of each component of the composite end point | three year | Each component of the composite end point |
| Rate of all-cause mortality | three year | Death due to all causes. |
| Rate of newly diagnosed prediabetes | three year | Prediabetes including impaired fasting glucose and abnormal glucose tolerance. |
| Rate of newly diagnosed hypertension | three year | Hypertension is defined as blood pressure≥140/90 millimeters of mercury measured twice at not same day. |
| Rate of composite endpoints of cardiovascular diseases 1 | three year | The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke. |
| Concentrations of serum lipid parameters | three year | Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, Lp(a). |
| Changes of abdominal circumference | three year | Measurement of abdominal circumference in centimeter |
| Changes of waist-hip ratio | three year | Measurement of waist-hip ratio |
| Changes of body mass index | three year | Measurement of body mass index in kg/m\^2 |
| Rate of newly diagnosed malignancy | three year | Newly diagnosed malignancy. |
Countries
China
Contacts
Primary ContactWenyao Wang, MD, PhD
Outcome results
None listed