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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Berberine

    Drug

    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

    Behavioral

    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.

Treatment groups

5,200 Participants
are divided into 2 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Berberine GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Rate of composite endpoints of cardiovascular diseases 1

The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke.

Time frame
three year
2

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
3

Rates of each component of the composite end point

Each component of the composite end point

Time frame
three year
4

Rate of all-cause mortality

Death due to all causes.

Time frame
three year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang Yida

Lead sponsor

Peking University Third Hospital

Sponsor institution

Chinese Society of Cardiology

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: