Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379379
• Other study ID #: DMR93-IRB-127
• Status: Completed
• Phase: N/A
• First received: September 20, 2006
• Last updated: September 20, 2006
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: September 2006
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Device:
• electroacupuncture

Locations

Country	Name	City	State
Taiwan	Graduate Insititude of Integration Chinese And Western Medicine, China Medical University	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	China Medical University, China

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. Epub 2006 May 17. — View 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. Epub 2005 Jan 20. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemic activity, plasma insulin level, HOMA index
Secondary	Triglyceride, cholesterol, free fatty acid