NCT05105321

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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,200

participants targeted

Target at P75+ for phase_4

Timeline
31mo left

Started Dec 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Dec 2021Dec 2028

First Submitted

Initial submission to the registry

October 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

October 16, 2021

Last Update Submit

November 1, 2021

Conditions

Metabolic Syndrome

Keywords

BerberineCardiovascular DiseasesDiabetesMetabolic SyndromePrimary Prevention

Outcome Measures

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.

    three year

Secondary Outcomes (11)

  • Rate of composite endpoints of cardiovascular diseases 1

    three year

  • Rate of composite end point of cardiovascular disease 2

    three year

  • Rates of each component of the composite end point

    three year

  • Rate of all-cause mortality

    three year

  • Rate of newly diagnosed prediabetes

    three year

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Drug: BerberineBehavioral: Healthy lifestyle intervention

Interventions

BerberineDRUG

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

Also known as: berberine hydrochloride
Berberine Group
Healthy lifestyle interventionBEHAVIORAL

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 GroupPlacebo Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (3)

  • 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.

    PMID: 30894319BACKGROUND

  • 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.

    PMID: 15531889BACKGROUND

  • 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.

    PMID: 25607236BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeCardiovascular DiseasesDiabetes Mellitus

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yi-Da Tang, MD, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenyao Wang, MD, PhD

CONTACT

0086-18810488381wwypumc@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief-Cardiologist and Director

Study Record Dates

First Submitted

October 16, 2021

First Posted

November 3, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

November 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)