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PreDiabetesPhase 4ABCDNCT05749874

Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus

A Phase 4 study testing Berberine plus lifestyle intervention in people with PreDiabetes and Abdominal Obesity, run by China National Center for Cardiovascular Diseases at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
PreDiabetes, Abdominal Obesity, Hypertension
What is being tested?
Berberine plus lifestyle intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,024 participants
Where
1 siteChina
Study dates
31 Oct 2023to 31 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.)
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Beijing

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Berberine plus lifestyle intervention, Placebo plus lifestyle intervention
Medical subject headings
Prediabetic State, Obesity, Abdominal, Hypertension, Dyslipidemias, Atherosclerosis

What participants receive

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

  • Berberine plus lifestyle interventionDrug

    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 plus lifestyle interventionBehavioural

    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.

Study groups in NCT05749874
Study groupRoleWhat they receive
berberine groupExperimentalBerberine hydrochloride plus lifestyle intervention
Receives: Drug: Berberine plus lifestyle intervention
placebo groupPlacebo comparatorPlacebo plus lifestyle intervention
Receives: Behavioral: Placebo plus lifestyle intervention

What is being measured

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

  1. The distribution of glycemic status at 1 year after randomization

    Categorized as normal glucose metabolism, prediabetes, and diabetes

    Measured: Intervention Period: 1 year

Secondary outcomes (16)

  1. Changes of glycemic-related parameters

    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)

    Measured: Intervention Period: 1 year

  2. Changes of lipid-related parameters

    Including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and lipoprotein(a)

    Measured: Intervention Period: 1 year

  3. Change of inflammation-related marker

    Including high-sensitivity C-reactive protein (hs-CRP)

    Measured: Intervention Period: 1 year

  4. Change of physical examination measures

    Including body mass index (BMI) and waist circumference

    Measured: Intervention Period: 1 year

  5. Changes of other parameters

    Including urinary albumin-to-creatinine ratio (UACR), serum uric acid, and metabolic syndrome score

    Measured: Intervention Period: 1 year

  6. Change of depressive symptoms

    Measured by Patient Health Questionnaire-9 (PHQ-9)

    Measured: Intervention Period: 1 year

  7. Time to first occurrence of composite endpoint of major cardiovascular event and diabetes

    cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization, and diabetes

    Measured: Intervention Period: 1 year

  8. Time to new-onset diabetes

    Diabetes is determined by oral glucose tolerance test, clinical diagnosis or use of glucose-lowering medications.

    Measured: Intervention Period: 1 year

  9. Normalization of glucose parameters

    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%.

    Measured: Intervention Period: 1 year

  10. Time to newly diagnosed cancer

    all events of cancer or classified by primary sites

    Measured: Intervention Period: 1 year

  11. Exploratory biomarker analyses

    Including serum trimethylamine, trimethylamine N-oxide, dopamine, berberine metabolites, and lipidomics analyses; urinary berberine metabolite analyses; and gut microbiota sequencing analyses.

    Measured: Intervention Period: 1 year

  12. Time to first occurrence of composite endpoint of major cardiovascular event and diabetes

    cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization, and diabetes

    Measured: Entire follow-up period: 4 years

  13. Time to new-onset diabetes

    Diabetes is determined by oral glucose tolerance test, clinical diagnosis or use of glucose-lowering medications.

    Measured: Entire follow-up period: 4 years

  14. Time to first occurrence of composite endpoint of major cardiovascular event 1

    cardiovascular death, non-hemorrhagic stroke, myocardial infarction, arterial revascularization

    Measured: Entire follow-up period: 4 years

  15. Time to first occurrence of composite endpoint of major cardiovascular event 2

    cardiovascular death, non-hemorrhagic stroke, myocardial infarction

    Measured: Entire follow-up period: 4 years

  16. Time to newly diagnosed cancer

    all events of cancer or classified by primary sites

    Measured: Entire follow-up period: 4 years

Timeline

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

  1. First posted1 Mar 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749874
Sponsor's protocol ID
2021-CXGC04-1
Acronym
ABCD
Status last verified
Dec 2025
First submitted
20 Feb 2023
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Kong WJ, Vernieri C, Foiani M, Jiang JD. Berberine in the treatment of metabolism-related chronic diseases: A drug cloud (dCloud) effect to target multifactorial disorders. Pharmacol Ther. 2020 May;209:107496. doi: 10.1016/j.pharmthera.2020.107496. Epub 2020 Jan 27.

    PubMed 32001311

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Berberine plus lifestyle intervention in people with PreDiabetes and Abdominal Obesity, run by China National Center for Cardiovascular Diseases 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 5 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The distribution of glycemic status at 1 year after randomization (time frame: Intervention Period: 1 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 NCT05749874, which also lists 2 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 31 Dec 2025.

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