Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)
ConditionMetabolic Syndrome
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorTang Yida
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Berberine
- Healthy lifestyle intervention
Treatment groups
5,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tang Yida
Lead sponsor
Peking University Third Hospital
Sponsor institution
Chinese Society of Cardiology
Collaborator
Source ClinicalTrials.gov