NCT00379379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

September 21, 2006

Status Verified

September 1, 2006

First QC Date

September 20, 2006

Last Update Submit

September 20, 2006

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Keywords

electroacupuncture, plasma glucose, plasma insulin

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemic activity, plasma insulin level, HOMA index

Secondary Outcomes (1)

  • Triglyceride, cholesterol, free fatty acid

Interventions

electroacupunctureDEVICE

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • disorders of hemostasis
  • patient had received insulin therapy
  • severe disease such as CVA, CAD within 6 months
  • Arrhythmia history and on pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taichung, 40402, Taiwan

Location

Related 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. doi: 10.1007/s001250051146.

    PMID: 10064107BACKGROUND

  • 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.

    PMID: 12052528BACKGROUND

  • 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.

    PMID: 15265586BACKGROUND

  • 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.

    PMID: 15814202BACKGROUND

  • 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.

    PMID: 16762373BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Shih-Liang Chang, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

January 1, 2005

Study Completion

December 1, 2005

Last Updated

September 21, 2006

Record last verified: 2006-09

Locations

TW(1)