Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

NCT ID: NCT00425009

Last Updated: 2007-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Berberine

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Jun Yin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Locations

Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

XH-2002-Clin4

Identifier Type: -

Identifier Source: org_study_id