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.
Trial 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. Read more about this study
- 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
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.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wenyao Wang, MD, PhD
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Tang Yida
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Society of Cardiology
- Responsible party
- Sponsor-investigator, Tang Yida, Peking University Third Hospital
- Investigators
- Yi-Da Tang, MD, PhD, Principal investigator, Peking University Third Hospital
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 30894319Kong 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 15531889Chang 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