Clinical trial

Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man

Name

BBR CLAMP

Description

Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could promote insulin secretion in mice and isolated islets. In this current study, investigators plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.

Trial arms

Trial start

2019-10-01

Estimated PCD

2020-01-20

Trial end

2020-02-17

Status

Completed

Phase

Early phase I

Treatment

Berberine Chloride

Traditional Chinese Medicine

Arms:

Berberine treatment, Placebo control

Placebo

Placebo Control

Arms:

Berberine treatment, Placebo control

Size

Primary endpoint

Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

Single dosage for one experiment and crossover repeat once after 2 weeks washout period

Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

Single dosage for one experiment and crossover repeat once after 2 weeks washout period

Eligibility criteria

Inclusion Criteria: 1. Adult healthy male, aged ≥18 and ≤45 years old. 2. Subject/ legal representative is able to understand and sign informed consent form. 3. Body mass index (BMI) 18-25 kg/m2. 4. Normal oral glucose tolerance test prior to study. 5. No family history of diabetes mellitus. 6. No medication treatment within 4 weeks prior to baseline visit and during the study. 7. Willing and able to comply with all study-related procedures, including not incorporating significant changes in diet. Exclusion Criteria: 1. Infection with hepatitis (A, B, or C), HIV and syphilis. 2. History of allergic reaction to berberine or any component in the formulation of the study drugs. 3. Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study. 4. Alcohol drinking within 2 weeks prior to baseline visit and during the study. 5. Use of illegal drugs or positive in urine drugs screen. 6. Smoke during the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

Updated at

2023-07-10

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug