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Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by China Medical University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00227383
First received: September 27, 2005
Last updated: January 19, 2007
Last verified: September 2005
History of Changes
  Purpose

In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.


Condition Intervention Phase
Diabetes Mellitus
Gastroparesis
 Device: Electroacupuncture (device)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks

Estimated Enrollment: 30
Detailed Description:

Initially, we will collect 30 patients with type 2 diabetes with a ≧ 3-month history of dyspeptic symptoms. An upper GI endocopy will be obtained to rule out possibility of organic obstruction. Cardiac arrhythmia and pregnancy will be excluded. None of them ever received abdominal surgery. Patients are then randomized to one of two treatment arms. Arm I: 15 patients received EA stimulation on acupoints St-36 (Zusanli) and Li-4 (Hegu). Arm II: 15 subjected to EA stimulation on non-acupoints around St-36 and Li-4 with the same electrical pulse and amplitude. Gastroparesis Cardinal Symptom Index (GCSI) and solid-phase gastric emptying time will be measured on baseline and after EA. In addition, serum gastrin, motilin, human pancreatic polypeptide, fasting blood sugar, and postprandial glucose levels will be also monitored.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Dyspetic symptoms for more than 3 months
  • Symptoms include nausea, vomiting, upper abdominal discomfort, early satiety, bloating and anorexia

Exclusion Criteria:

  • Organic gastrointestinal obstruction
  • Previous surgery of gastrointestinal tract
  • Cardiac arrhythmia
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227383

Contacts
Contact: Chung-Pang Wang, MD 886-4-22052121 ext 1431 cpw0509@yahoo.com.tw

Locations
Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 404
Contact: Chung-Pang Wang, MD     886-4-22052121 ext 1431        
Principal Investigator: Chung-Pang Wang            
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Chair: Chung-Pang Wang, MD China Medical University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00227383     History of Changes
Other Study ID Numbers: DMR94-IRB-69
Study First Received: September 27, 2005
Last Updated: January 19, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Diabetes
gastroparesis
electroacupuncture

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013