🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05105321
Starting soon Phase 4

Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)

NCT05105321 · tracked via the Priya Life Science China tracker
Sponsor
Tang Yida
Phase
Phase 4
Started
2021-12
Last updated
2021-11-03

Condition(s) studied

Metabolic Syndrome

Investigational drug(s) / intervention(s)

BerberineHealthy lifestyle intervention

Berberine: 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: 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.

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality

More Tang Yida trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05105321 on ClinicalTrials.gov ↗ ← All trials in China