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临床试验/NCT00425009
NCT00425009已完成1 期

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

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2004年1月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
HbA1c at 13 weeks

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Liver damage
  • Kidney damage

结局指标

主要结局

HbA1c at 13 weeks

次要结局

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

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other

研究点 (1)

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