Study of Improving Insulin Sensitivity by Electroacupunct... | NCT00379379

Studies
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

NCT00379379

Sponsor

China Medical University Hospital

Status

Completed

Last Update Posted

Sep 21, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2
Insulin Resistance

Interventions

electroacupuncture

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Sep 20, 2006

First Submission Date that Met QC Criteria

Sep 20, 2006

First Posted Date

Sep 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2006

Last Update Posted Date

Sep 21, 2006Estimated

Name	Class
China Medical University, China	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
electroacupuncture	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypoglycemic activity, plasma insulin level, HOMA index

Secondary Outcomes

Measure	Description	Time Frame
Triglyceride, cholesterol, free fatty acid

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shih-Liang Chang, M.D., Ph.D.	Graduate Institude of Integration Chinese and Western Medicine, China Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate Insititude of Integration Chinese And Western Medicine, China Medical University		Taichung		40402	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10064107	Background	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.
12052528	Background	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D015670	Acupuncture Therapy
D000529	Complementary Therapies

ID	Term
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance