Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus (ABCD)

December 25, 2025 updated by: China National Center for Cardiovascular Diseases

Assess the Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus Among Individuals With High Cardiometabolic Risk

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine on preventing cardiovascular disease and diabetes mellitus among individuals with high cardiometabolic risk in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial aims to evaluate the efficacy and safety of berberine treatment for individuals with high cardiometabolic risk. Potential eligible patients will be recruited from about 100 medical centers in China. After a 4-to-6-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 500mg twice a day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be followed up at month 3 and month 6, and once every 3 months thereafter, and be followed up for 3 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2024

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants aged ≥40 years old
  • Participants with prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%
  • Participants with body mass index>25kg/m2, or abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
  • Participants with established atherosclerosis cardiovascular diseases (ASCVD), or with at least two cardiovascular risk factors: (a) hypertension (b) aged ≥45(male) / 55 (female), (c) current smoker, (d) HDL-C<1mmol/L or TG≥2.3mmol/L
  • Participants with established ASCVD required LDL-C≤70 mg/dL (1.8mmol/L) for participants with ASCVD or receiving optimized LDL-C-lowering therapy (at least moderate-intensity statin therapy, unless contraindicated or intolerant)

Exclusion Criteria:

  • Participants with FPG≥7.0 mmol/L, diagnosed with diabetes or taking oral glucose-lowering drugs
  • Participants diagnosed with acute coronary syndrome, stroke, transient ischemic attack, or undergoing cardiac surgery or cardiac intervention (i.e., implantation of cardiac closure devices, cardiac resynchronization therapy, or catheter ablation), percutaneous coronary intervention or valvuloplasty/other cardiac valve repair or implantation surgery within the 3 months before randomization
  • Participants who plan to perform coronary and/or non coronary revascularization surgery, or cardiac surgery within 6 months after randomization
  • Participants diagnosed with heart failure or left ventricular ejection fraction<40%, severe cardiac valvular disease, cardiomyopathy, congenital heart disease
  • Conditions known to interfere with the accuracy of HbA1c measurement, including rheumatoid arthritis, hemolytic anemia, aplastic anemia, hemoglobinopathies, splenomegaly, splenectomy, vitamin B12 deficiency, alcoholism, long-term high-dose aspirin use, or chronic use of anesthetics or hydroxyurea
  • Recipients of major organ transplants (e.g., lung, liver, heart, bone marrow, kidneys, etc.)
  • Participants diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Participants taking berberine or drug containing berberine in the past 1 month
  • Participants with any adverse reaction to berberine
  • Participants with severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
  • Participants who plan to have weight loss surgery, plan to take or currently taking drugs for weight loss
  • Participants with active liver diseases, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) > 3 times upper limit of normal
  • Estimated glomerular filtration rate (eGFR) < 45 ml/(min×1.73m2)
  • Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial
  • Participants with malignant tumors, or other serious diseases with life expectancy of less than 3 years
  • Participants with mental disorders, cognitive disorders, or other serious diseases that could affect study participation
  • Participants who participated or have been participating other trials during the last 3 months
  • Any other conditions that may hinder the compliance to the study intervention or follow-up visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: berberine group
Berberine hydrochloride plus lifestyle intervention
Drug: Berberine plus lifestyle intervention
berberine hydrochloride 500mg twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.
Placebo Comparator: placebo group
Placebo plus lifestyle intervention
Behavioral: Placebo plus lifestyle intervention
Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on Chinese guideline for primary prevention of cardiovascular diseases, and Chinese guideline for management of type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke. Intervention includes health education on smoking, alcohol consumption, diet, physical activity and weight loss, etc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The distribution of glycemic status at 1 year after randomization
Time Frame: Intervention Period: 1 year
Categorized as normal glucose metabolism, prediabetes, and diabetes
Intervention Period: 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of glycemic-related parameters
Time Frame: Intervention Period: 1 year
Including hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of β-cell function (HOMA-β)
Intervention Period: 1 year
Changes of lipid-related parameters
Time Frame: Intervention Period: 1 year
Including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and lipoprotein(a)
Intervention Period: 1 year
Change of inflammation-related marker
Time Frame: Intervention Period: 1 year
Including high-sensitivity C-reactive protein (hs-CRP)
Intervention Period: 1 year
Change of physical examination measures
Time Frame: Intervention Period: 1 year
Including body mass index (BMI) and waist circumference
Intervention Period: 1 year
Changes of other parameters
Time Frame: Intervention Period: 1 year
Including urinary albumin-to-creatinine ratio (UACR), serum uric acid, and metabolic syndrome score
Intervention Period: 1 year
Change of depressive symptoms
Time Frame: Intervention Period: 1 year
Measured by Patient Health Questionnaire-9 (PHQ-9)
Intervention Period: 1 year
Time to first occurrence of composite endpoint of major cardiovascular event and diabetes
Time Frame: Intervention Period: 1 year
cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization, and diabetes
Intervention Period: 1 year
Time to new-onset diabetes
Time Frame: Intervention Period: 1 year
Diabetes is determined by oral glucose tolerance test, clinical diagnosis or use of glucose-lowering medications.
Intervention Period: 1 year
Normalization of glucose parameters
Time Frame: Intervention Period: 1 year
Meeting all three criteria: 1) Fasting plasma glucose (FPG)<6.1 mmol/L; 2) 2-hour postprandial blood glucose (2hPG)<7.8 mmol/L; 3) HbA1c<5.7%.
Intervention Period: 1 year
Time to newly diagnosed cancer
Time Frame: Intervention Period: 1 year
all events of cancer or classified by primary sites
Intervention Period: 1 year
Exploratory biomarker analyses
Time Frame: Intervention Period: 1 year
Including serum trimethylamine, trimethylamine N-oxide, dopamine, berberine metabolites, and lipidomics analyses; urinary berberine metabolite analyses; and gut microbiota sequencing analyses.
Intervention Period: 1 year
Time to first occurrence of composite endpoint of major cardiovascular event and diabetes
Time Frame: Entire follow-up period: 4 years
cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization, and diabetes
Entire follow-up period: 4 years
Time to new-onset diabetes
Time Frame: Entire follow-up period: 4 years
Diabetes is determined by oral glucose tolerance test, clinical diagnosis or use of glucose-lowering medications.
Entire follow-up period: 4 years
Time to first occurrence of composite endpoint of major cardiovascular event 1
Time Frame: Entire follow-up period: 4 years
cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization
Entire follow-up period: 4 years
Time to first occurrence of composite endpoint of major cardiovascular event 2
Time Frame: Entire follow-up period: 4 years
cardiovascular death, non-hemorrhagic stroke, myocardial infarction
Entire follow-up period: 4 years
Time to newly diagnosed cancer
Time Frame: Entire follow-up period: 4 years
all events of cancer or classified by primary sites
Entire follow-up period: 4 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup analysis 1 for primary outcome measure
Time Frame: Intervention Period: 1 year
Age (<55，55-65，≥65)
Intervention Period: 1 year
Subgroup analysis 2 for primary outcome measure
Time Frame: Intervention Period: 1 year
Sex (male, female)
Intervention Period: 1 year
Subgroup analysis 3 for primary outcome measure
Time Frame: Intervention Period: 1 year
Body mass index (<28kg/m2, ≥28kg/m2)
Intervention Period: 1 year
Subgroup analysis 4 for primary outcome measure
Time Frame: Intervention Period: 1 year
Statin use (yes, no)
Intervention Period: 1 year
Subgroup analysis 5 for primary outcome measure
Time Frame: Intervention Period: 1 year
HbA1c median
Intervention Period: 1 year
Subgroup analysis 6 for primary outcome measure
Time Frame: Intervention Period: 1 year
Hs-CRP tertiles
Intervention Period: 1 year
Subgroup analysis 7 for primary outcome measure
Time Frame: Intervention Period: 1 year
LDL-C tertiles
Intervention Period: 1 year
Subgroup analysis 8 for primary outcome measure
Time Frame: Intervention Period: 1 year
Triglyceride tertiles
Intervention Period: 1 year
Subgroup analysis 9 for primary outcome measure
Time Frame: Intervention Period: 1 year
HDL-C tertiles
Intervention Period: 1 year
Safety assessment during the intervention period
Time Frame: Intervention Period: 1 year
Including serious adverse events, non-serious adverse events of special interest, and treatment discontinuation for any reason
Intervention Period: 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Li, PhD, National Center for Cardiovascular Diseases
  • Principal Investigator: Haibo Zhang, MD, National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-CXGC04-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All the IPD that underlie results in the publication with study protocol and SAP will be shared to the public on the study website upon request with a protocol after approval from the ABCD steering committee. The access criteria and URL of the study website is not established yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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