Berberine Hyperglycemic Clamp

Early Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Berberine Chloride; Drug: Placebo

• Registration Number: NCT03972215
• Lead Sponsor: Jin-Kui Yang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Study Start: 2019-10-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-02-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo control	Berberine Chloride	-
Berberine treatment	Berberine Chloride	-
Placebo control	Placebo	-
Berberine treatment	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China