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

NCT ID: NCT05105321

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 5200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2028-12-31

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.

Conditions

Metabolic Syndrome

Keywords

Berberine; Cardiovascular Diseases; Diabetes; Metabolic Syndrome; Primary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo Group

Placebo plus healthy lifestyle intervention. Placebo with same appearance of berberine tablet will be orally taken twice daily and maintained until the last subject completes 3-year intervention.

Group Type: PLACEBO_COMPARATOR

Healthy lifestyle intervention

Intervention Type: 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.

Berberine Group

Berberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention.

Group Type: EXPERIMENTAL

Berberine

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

berberine hydrochloride

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Society of Cardiology

OTHER

Sponsor Role: collaborator

Tang Yida

OTHER

Sponsor Role: lead

Responsible Party

Tang Yida

Chief-Cardiologist and Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi-Da Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Wenyao Wang, MD, PhD

Role: CONTACT

Phone: 0086-18810488381

Email: wwypumc@126.com

Facility Contacts

Wenyao Wang, MD, PhD

Role: primary

References

Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Sep 10;74(10):1376-1414. doi: 10.1016/j.jacc.2019.03.009. Epub 2019 Mar 17.

Reference Type: BACKGROUND

PMID: 30894319 (View on PubMed)

Kong W, Wei J, Abidi P, Lin M, Inaba S, Li C, Wang Y, Wang Z, Si S, Pan H, Wang S, Wu J, Wang Y, Li Z, Liu J, Jiang JD. Berberine is a novel cholesterol-lowering drug working through a unique mechanism distinct from statins. Nat Med. 2004 Dec;10(12):1344-51. doi: 10.1038/nm1135. Epub 2004 Nov 7.

Reference Type: BACKGROUND

PMID: 15531889 (View on PubMed)

Chang W, Chen L, Hatch GM. Berberine as a therapy for type 2 diabetes and its complications: From mechanism of action to clinical studies. Biochem Cell Biol. 2015 Oct;93(5):479-86. doi: 10.1139/bcb-2014-0107. Epub 2014 Dec 1.

Reference Type: BACKGROUND

PMID: 25607236 (View on PubMed)

Other Identifiers

CSCF2021A04

Identifier Type: -

Identifier Source: org_study_id