Skip to main content
OpenTrials
Completed

NCT Number: NCT03972215

Berberine Hyperglycemic Clamp

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berberine Chloride

Drug

Traditional Chinese Medicine

Placebo

Drug

Placebo Control

Primary outcomes

  1. Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

    Time frame: 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.

  2. Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

    Time frame: 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 outcomes

  1. Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

    Time frame: 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.

  2. Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.

    Time frame: 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 outcomes

  1. Heart rate and QT-interval duration using electrocardiogram before and after drug treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jin-Kui Yang

Other

Registry information

Official study title

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

Acronym: BBR HC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2019
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.