NCT03972215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for early_phase_1 diabetes-mellitus

Timeline
Completed

Started Oct 2019

Shorter than P25 for early_phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

May 29, 2019

Last Update Submit

July 7, 2023

Conditions

Diabetes Mellitus

Keywords

Hyperglycemic Clamp

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • 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

  • 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

Other Outcomes (1)

  • 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

Study Arms (2)

Berberine treatment

EXPERIMENTAL
Drug: Berberine ChlorideDrug: Placebo

Placebo control

PLACEBO COMPARATOR
Drug: Berberine ChlorideDrug: Placebo

Interventions

Berberine ChlorideDRUG

Traditional Chinese Medicine

Berberine treatmentPlacebo control
PlaceboDRUG

Placebo Control

Berberine treatmentPlacebo control

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • 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.

    PMID: 34556670DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 3, 2019

Study Start

October 1, 2019

Primary Completion

January 20, 2020

Study Completion

February 17, 2020

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)