Clinical trial NCT03972215: Berberine Hyperglycemic Clamp
Official title: Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus
Keywords: Hyperglycemic Clamp
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


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.

Primary outcomes:
measure: Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
timeFrame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
measure: Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
timeFrame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Secondary outcomes:
measure: Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
timeFrame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
measure: Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
timeFrame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Other outcomes:
measure: Heart rate and QT-interval duration using electrocardiogram before and after drug treatment.
timeFrame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
References:
citation: Zhao MM, Lu J, Li S, Wang H, Cao X, Li Q, Shi TT, Matsunaga K, Chen C, Huang H, Izumi T, Yang JK. Berberine is an insulin secretagogue targeting the KCNH6 potassium channel. Nat Commun. 2021 Sep 23;12(1):5616. doi: 10.1038/s41467-021-25952-2.