Berberine Hyperglycemic Clamp

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-02-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Berberine treatment

Group Type EXPERIMENTAL

Berberine Chloride

Intervention Type DRUG

Traditional Chinese Medicine

Placebo

Intervention Type DRUG

Placebo Control

Placebo control

Group Type PLACEBO_COMPARATOR

Berberine Chloride

Intervention Type DRUG

Traditional Chinese Medicine

Placebo

Intervention Type DRUG

Placebo Control

Interventions

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Berberine Chloride

Traditional Chinese Medicine

Intervention Type DRUG

Placebo

Placebo Control

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes