Berberine Hyperglycemic Clamp

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Berberine Chloride
* Drug: Placebo


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine treatment<br> | Drug: Berberine Chloride<br>* Traditional Chinese Medicine<br>Drug: Placebo<br>* Placebo Control<br>|
| Placebo Comparator: Placebo control<br> | Drug: Berberine Chloride<br>* Traditional Chinese Medicine<br>Drug: Placebo<br>* Placebo Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperglycemic Clamp