Berberine Hyperglycemic Clamp

Early Phase 1CompletedNCT03972215

Jin-Kui Yang15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Berberine ChlorideDRUG

Traditional Chinese Medicine

PlaceboDRUG

Placebo Control

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study.

Time frame: 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.

To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study.

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

Secondary Outcomes

Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

To compare the mean glucose infusion rates in the two groups during hyperglycemic clamp study.

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

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

To compare the mean blood glucose levels in the two groups during hyperglycemic clamp study.

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

Data from ClinicalTrials.gov

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