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Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

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ClinicalTrials.gov Identifier: NCT00379379
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : September 21, 2006
Sponsor:
Collaborator:
China Medical University, China
Information provided by:
China Medical University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Insulin Resistance Device: electroacupuncture Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy
Study Start Date : January 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Hypoglycemic activity, plasma insulin level, HOMA index

Secondary Outcome Measures :
  1. Triglyceride, cholesterol, free fatty acid


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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379379


Locations
Taiwan
Graduate Insititude of Integration Chinese And Western Medicine, China Medical University
Taichung, Taiwan, 40402
Sponsors and Collaborators
China Medical University Hospital
China Medical University, China
Investigators
Principal Investigator: Shih-Liang Chang, M.D., Ph.D. Graduate Institude of Integration Chinese and Western Medicine, China Medical University

Publications:
ClinicalTrials.gov Identifier: NCT00379379     History of Changes
Other Study ID Numbers: DMR93-IRB-127
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: September 21, 2006
Last Verified: September 2006

Keywords provided by China Medical University Hospital:
electroacupuncture, plasma glucose, plasma insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs