Metabolic SyndromePhase 4CDPPNCT05105321

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

A Phase 4 study testing Berberine and Healthy lifestyle intervention in people with Metabolic Syndrome, run by Tang Yida at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Berberine and Healthy lifestyle intervention
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,200 participants
Where: 1 siteChina
Study dates: Dec 2021to Dec 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenyao Wang, MD, PhD contact

0086-18810488381

wwypumc@126.com

China1 site

Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wenyao Wang, MD, PhD

Other trials in China

About this study

Official title: Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled 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).

Read the 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
Being tested: Berberine, Healthy lifestyle intervention
Keywords: Berberine, Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Primary Prevention
Medical subject headings: Metabolic Syndrome, Cardiovascular Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BerberineDrug
Also called berberine hydrochloride
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 interventionBehavioural
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 groups in NCT05105321
Study group	Role	What they receive
Placebo Group	Placebo comparator	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. Receives: Behavioral: Healthy lifestyle intervention
Berberine Group	Experimental	Berberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention. Receives: Drug: Berberine; Behavioral: Healthy lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of composite cardiometabolic endpoints
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.
Measured: three year

Secondary outcomes (11)

Rate of composite endpoints of cardiovascular diseases 1
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke.
Measured: three year
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.
Measured: three year
Rates of each component of the composite end point
Each component of the composite end point
Measured: three year
Rate of all-cause mortality
Death due to all causes.
Measured: three year
Rate of newly diagnosed prediabetes
Prediabetes including impaired fasting glucose and abnormal glucose tolerance.
Measured: three year
Rate of newly diagnosed hypertension
Hypertension is defined as blood pressure≥140/90 millimeters of mercury measured twice at not same day.
Measured: three year
Rate of newly diagnosed malignancy
Newly diagnosed malignancy.
Measured: three year
Concentrations of serum lipid parameters
Serum lipid parameters including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, Lp(a).
Measured: three year
Changes of abdominal circumference
Measurement of abdominal circumference in centimeter
Measured: three year
Changes of waist-hip ratio
Measurement of waist-hip ratio
Measured: three year
Changes of body mass index
Measurement of body mass index in kg/m^2
Measured: three year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2021Dec 2028

First posted3 Nov 2021
Study startDec 2021 (estimated)
Primary completionDec 2026 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 5,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05105321
Sponsor's protocol ID: CSCF2021A04
Acronym: CDPP
Status last verified: Nov 2021
First submitted: 16 Oct 2021
Last updated: 3 Nov 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 30894319
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.
PubMed 15531889
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.
PubMed 25607236

Interested in taking part?

Wenyao Wang, MD, PhD

0086-18810488381

wwypumc@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Effects of Meal Macronutrients on Postprandial Lipids
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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT05105321
Acronym / sponsor ID: CDPP / CSCF2021A04
Conditions: Metabolic Syndrome
Keywords: Berberine, Cardiovascular Diseases, Diabetes, Metabolic Syndrome, Primary Prevention
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 5,200 participants (estimated)
Lead sponsor: Tang YidaUniversity, hospital or other
Collaborators: Chinese Society of Cardiology
Study start: Dec 2021 (estimated)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 3 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Group	Placebo comparator	Behavioral: Healthy lifestyle interventionPlacebo 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 Group	Experimental	Drug: Berberine, Behavioral: Healthy lifestyle interventionBerberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BerberineAlso: berberine hydrochlorideThe 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	Drug	Berberine Group
Healthy lifestyle interventionHealthy 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.	Behavioural	Berberine Group, Placebo Group

Primary outcome

Rate of composite cardiometabolic endpoints
Time frame: three year
The composite endpoints including cardiac death, nonfatal myocardial infarction, nonfatal stroke, and newly-diagnosed type 2 diabetes.

11 secondary outcomes

Rate of composite endpoints of cardiovascular diseases 1
Time frame: three year
Rate of composite end point of cardiovascular disease 2
Time frame: three year
Rates of each component of the composite end point
Time frame: three year
Rate of all-cause mortality
Time frame: three year
Rate of newly diagnosed prediabetes
Time frame: three year
Rate of newly diagnosed hypertension
Time frame: three year
Rate of newly diagnosed malignancy
Time frame: three year
Concentrations of serum lipid parameters
Time frame: three year
Changes of abdominal circumference
Time frame: three year
Changes of waist-hip ratio
Time frame: three year
Changes of body mass index
Time frame: three year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
Background: PubMed 30894319Arnett 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.
Background: PubMed 15531889Kong 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.
Background: PubMed 25607236Chang 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.
Individual participant dataSharing planned: No. 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.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wenyao Wang, MD, PhD contact

0086-18810488381

wwypumc@126.com

Yi-Da Tang, MD, PhD principal investigator

Peking University Third Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Berberine and Healthy lifestyle intervention in people with Metabolic Syndrome, run by Tang Yida at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenyao Wang, MD, PhD (0086-18810488381, wwypumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of composite cardiometabolic endpoints (time frame: three year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05105321, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.