BBR HC: Berberine Hyperglycemic Clamp

Sponsor

Jin-Kui Yang (Other)

Overall Status

Completed

CT.gov ID

NCT03972215

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Berberine Chloride Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Jan 20, 2020

Actual Study Completion Date :

Feb 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Berberine treatment	Drug: Berberine Chloride Traditional Chinese Medicine Drug: Placebo Placebo Control
Placebo Comparator: Placebo control	Drug: Berberine Chloride Traditional Chinese Medicine Drug: Placebo Placebo Control

Arm

Intervention/Treatment

Experimental: Berberine treatment

Drug: Berberine Chloride

Traditional Chinese Medicine

Drug: Placebo

Placebo Control

Placebo Comparator: Placebo control

Drug: Berberine Chloride

Traditional Chinese Medicine

Drug: Placebo

Placebo Control

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing	China	100730

Sponsors and Collaborators

Jin-Kui Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Kui Yang, Professor, PhD, Beijing Tongren Hospital

ClinicalTrials.gov Identifier:

NCT03972215

Other Study ID Numbers:

BBR CLAMP

First Posted:

Jun 3, 2019

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jin-Kui Yang, Professor, PhD, Beijing Tongren Hospital

Hyperglycemic Clamp

Study Results

No Results Posted as of Feb 24, 2020