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NCT Number: NCT00379379

Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Insititude of Integration Chinese And Western Medicine, China Medical University

Taichung, 40402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Electroacupuncture

Device

Primary outcomes

  1. Hypoglycemic activity, plasma insulin level, HOMA index

Secondary outcomes

  1. Triglyceride, cholesterol, free fatty acid

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • China Medical University, China

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Sep 21, 2006
Registry last updated
Sep 21, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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