Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

NCT ID: NCT00379379

Last Updated: 2006-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Insulin Resistance

Keywords

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electroacupuncture, plasma glucose, plasma insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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electroacupuncture

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Shih-Liang Chang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Graduate Institude of Integration Chinese and Western Medicine, China Medical University

Locations

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

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 10064107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12052528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15265586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15814202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16762373 (View on PubMed)

Other Identifiers

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DMR93-IRB-127

Identifier Type: -

Identifier Source: org_study_id