Back to results

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

Primary Purpose

Metabolic Syndrome

Status

Not yet recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Berberine

Healthy lifestyle intervention

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Berberine, Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Primary Prevention

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Berberine Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of composite cardiometabolic endpoints

The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.

Secondary Outcome Measures

Rate of composite endpoints of cardiovascular diseases 1

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

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.

Rates of each component of the composite end point

Each component of the composite end point

Rate of all-cause mortality

Death due to all causes.

Rate of newly diagnosed prediabetes

Prediabetes including impaired fasting glucose and abnormal glucose tolerance.

Rate of newly diagnosed hypertension

Hypertension is defined as blood pressure≥140/90 millimeters of mercury measured twice at not same day.

Rate of newly diagnosed malignancy

Newly diagnosed malignancy.

Concentrations of serum lipid parameters

Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, Lp(a).

Changes of abdominal circumference

Measurement of abdominal circumference in centimeter

Changes of waist-hip ratio

Measurement of waist-hip ratio

Changes of body mass index

Measurement of body mass index in kg/m^2

Full Information

NCT ID

NCT05105321

First Posted

October 16, 2021

Last Updated

November 1, 2021

Sponsor

Tang Yida

Collaborators

Chinese Society of Cardiology

1. Study Identification

Unique Protocol Identification Number

NCT05105321

Brief Title

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

Acronym

CDPP

Official Title

Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tang Yida

Collaborators

Chinese Society of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Berberine Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Berberine

Other Intervention Name(s)

berberine hydrochloride

Intervention Description

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

Behavioral

Intervention Name(s)

Healthy lifestyle intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of composite cardiometabolic endpoints

Description

The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.

Time Frame

three year

Secondary Outcome Measure Information:

Title

Rate of composite endpoints of cardiovascular diseases 1

Description

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

Time Frame

three year

Title

Rate of composite end point of cardiovascular disease 2

Description

The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, successful resuscitation of cardiac arrest, heart failure, arterial revascularization.

Time Frame

three year

Title

Rates of each component of the composite end point

Description

Each component of the composite end point

Time Frame

three year

Title

Rate of all-cause mortality

Description

Death due to all causes.

Time Frame

three year

Title

Rate of newly diagnosed prediabetes

Description

Prediabetes including impaired fasting glucose and abnormal glucose tolerance.

Time Frame

three year

Title

Rate of newly diagnosed hypertension

Description

Hypertension is defined as blood pressure≥140/90 millimeters of mercury measured twice at not same day.

Time Frame

three year

Title

Rate of newly diagnosed malignancy

Description

Newly diagnosed malignancy.

Time Frame

three year

Title

Concentrations of serum lipid parameters

Description

Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, Lp(a).

Time Frame

three year

Title

Changes of abdominal circumference

Description

Measurement of abdominal circumference in centimeter

Time Frame

three year

Title

Changes of waist-hip ratio

Description

Measurement of waist-hip ratio

Time Frame

three year

Title

Changes of body mass index

Description

Measurement of body mass index in kg/m^2

Time Frame

three year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenyao Wang, MD, PhD

Phone

0086-18810488381

wwypumc@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi-Da Tang, MD, PhD

Organizational Affiliation

Peking University Third Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Third Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenyao Wang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data, analytic methods, and study materials will not be made available immediately to other researchers. The reason for the lack of availability is that we have signed an agreement with the sponsor to restrict approach to study data, and the access must be agreed by both investigator and sponsor. Request to get these materials can be sent to the corresponding author, and we will provide them to vetted and qualified applicants.

Citations:

PubMed Identifier

30894319

Citation

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. Erratum In: J Am Coll Cardiol. 2019 Sep 10;74(10):1428-1429. J Am Coll Cardiol. 2020 Feb 25;75(7):840.

Results Reference

background

PubMed Identifier

15531889

Citation

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.

Results Reference

background

PubMed Identifier

25607236

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs