Therapeutic Effects of Berberine in Patients With Type 2 Diabetes
The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes|
- HbA1c at 13 weeks
- Blood glucose at 13 weeks
- Blood lipids at 13 weeks
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||December 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425009
|Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine|
|Shanghai, China, 200092|
|Principal Investigator:||Jun Yin, MD, PhD||Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine|