Berberine Hyperglycemic Clamp

Diabetes Mellitus Clinical Trial

— BBR HC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972215
• Other study ID #: BBR CLAMP
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1, 2019
• Est. completion date: February 17, 2020

Study information

• Verified date: July 2023
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 17, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Berberine Chloride
Traditional Chinese Medicine
• Placebo
Placebo Control

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jin-Kui Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate and QT-interval duration using electrocardiogram before and after drug treatment.	Electrocardiogram will be performed in subjects before and after drug treatment.	Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Primary	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
Primary	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	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
Secondary	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