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Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

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ClinicalTrials.gov Identifier: NCT00227383
Recruitment Status : Unknown
Verified September 2005 by China Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2005
Last Update Posted : January 22, 2007
Sponsor:
Information provided by:
China Medical University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Gastroparesis Device: Electroacupuncture (device) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227383


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

Locations
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Taiwan
China Medical University Hospital
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
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Study Chair: Chung-Pang Wang, MD China Medical University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00227383    
Other Study ID Numbers: DMR94-IRB-69
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: January 22, 2007
Last Verified: September 2005
Keywords provided by China Medical University Hospital:
Diabetes
gastroparesis
electroacupuncture
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations