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Clinical Trials/NCT00425009
NCT00425009
Completed
Phase 1

Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes

Shanghai Jiao Tong University School of Medicine1 site in 1 country70 target enrollmentJanuary 2004

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
70
Locations
1
Primary Endpoint
HbA1c at 13 weeks
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.

Detailed Description

Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes. Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
December 2004
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of type 2 diabetes
  • HbA1c \> 7.0% or FBG \> 7.0 mmol/L
  • Stable or worsening glycemic control for at least 3 months

Exclusion Criteria

  • Liver damage
  • Kidney damage

Outcomes

Primary Outcomes

HbA1c at 13 weeks

Secondary Outcomes

  • Blood glucose at 13 weeks
  • Blood lipids at 13 weeks

Study Sites (1)

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