Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Phase 1

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00425009
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-12
• Status Verified: 2007-01
• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Last Update Submitted: 2007-01-18
• Study First Posted: 2007-01-22
• Last Update Posted: 2007-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c at 13 weeks

Secondary Outcome Measures

Name	Time	Method
Blood glucose at 13 weeks
Blood lipids at 13 weeks

Trial Locations

Locations (1)

Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China