Diabetes Mellitus
Conditions
Keywords
Hyperglycemic Clamp
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.
Interventions
Traditional Chinese Medicine
DRUGPlacebo
Placebo Control
Sponsors
Jin-Kui Yang
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study. |
| Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | To compare the mean glucose infusion rates in the two groups during hyperglycemic clamp study. |
| Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | To compare the mean blood glucose levels in the two groups during hyperglycemic clamp study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart rate and QT-interval duration using electrocardiogram before and after drug treatment. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period | Electrocardiogram will be performed in subjects before and after drug treatment. |
Countries
China
Outcome results
None listed