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Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring electroacupuncture, plasma glucose, plasma insulin

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Hypoglycemic activity, plasma insulin level, HOMA index

Secondary Outcome Measures

Triglyceride, cholesterol, free fatty acid

Full Information

First Posted
September 20, 2006
Last Updated
September 20, 2006
Sponsor
China Medical University Hospital
Collaborators
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT00379379
Brief Title
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy
Official Title
Study of Improving Insulin Sensitivity by Combined Both Electroacupuncture and Drug Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital
Collaborators
China Medical University, China

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Resistance
Keywords
electroacupuncture, plasma glucose, plasma insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
26 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
electroacupuncture
Primary Outcome Measure Information:
Title
Hypoglycemic activity, plasma insulin level, HOMA index
Secondary Outcome Measure Information:
Title
Triglyceride, cholesterol, free fatty acid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Liang Chang, M.D., Ph.D.
Organizational Affiliation
Graduate Institude of Integration Chinese and Western Medicine, China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Insititude of Integration Chinese And Western Medicine, China Medical University
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
10064107
Citation
Chang SL, Lin JG, Chi TC, Liu IM, Cheng JT. An insulin-dependent hypoglycaemia induced by electroacupuncture at the Zhongwan (CV12) acupoint in diabetic rats. Diabetologia. 1999 Feb;42(2):250-5. doi: 10.1007/s001250051146.
Results Reference
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PubMed Identifier
12052528
Citation
Lin JG, Chang SL, Cheng JT. Release of beta-endorphin from adrenal gland to lower plasma glucose by the electroacupuncture at Zhongwan acupoint in rats. Neurosci Lett. 2002 Jun 21;326(1):17-20. doi: 10.1016/s0304-3940(02)00331-2.
Results Reference
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PubMed Identifier
15265586
Citation
Lin JG, Chen WC, Hsieh CL, Tsai CC, Cheng YW, Cheng JT, Chang SL. Multiple sources of endogenous opioid peptide involved in the hypoglycemic response to 15 Hz electroacupuncture at the Zhongwan acupoint in rats. Neurosci Lett. 2004 Aug 5;366(1):39-42. doi: 10.1016/j.neulet.2004.05.003.
Results Reference
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PubMed Identifier
15814202
Citation
Chang SL, Tsai CC, Lin JG, Hsieh CL, Lin RT, Cheng JT. Involvement of serotonin in the hypoglycemic response to 2 Hz electroacupuncture of zusanli acupoint (ST36) in rats. Neurosci Lett. 2005 Apr 29;379(1):69-73. doi: 10.1016/j.neulet.2004.12.057. Epub 2005 Jan 20.
Results Reference
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PubMed Identifier
16762373
Citation
Chang SL, Lin KJ, Lin RT, Hung PH, Lin JG, Cheng JT. Enhanced insulin sensitivity using electroacupuncture on bilateral Zusanli acupoints (ST 36) in rats. Life Sci. 2006 Aug 1;79(10):967-71. doi: 10.1016/j.lfs.2006.05.005. Epub 2006 May 17.
Results Reference
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Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

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