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临床试验/NCT00379379
NCT00379379已完成不适用

Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Hypoglycemic activity, plasma insulin level, HOMA index

研究概览

简要总结

The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.

详细描述

Some previous animal model studies reveal that electroacupuncture (EA) applying on specific acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and encourage insulin secretion, even improve insulin resistance. In this study, we want to observe these results on type II diabetic patients who have been diagnosed in five years under a study design of randomized control trial (RCT) to obtain evidence on clinical.

We undertook a randomized, single blind and sham group controlled study to evaluate the effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint. A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA treatment, and the other 13 patients are divided into control group (CG) with sham treatment. The main outcome is the changes of laboratory parameters between before and 30 minutes after the test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed NIDDM patient within 5 years
  • age between 30 to 65 years old
  • controlled BP below 140/90 mmHg
  • oral hypoglycemic agent (OHA) therapy with Gliclazide twice per day.

排除标准

  • disorders of hemostasis
  • patient had received insulin therapy
  • severe disease such as CVA, CAD within 6 months
  • Arrhythmia history and on pacemaker.

结局指标

主要结局

Hypoglycemic activity, plasma insulin level, HOMA index

次要结局

  • Triglyceride, cholesterol, free fatty acid

研究者

申办方类型
Other

研究点 (2)

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