Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

Tracking Information
First Submitted Date ICMJE	September 27, 2005
First Posted Date ICMJE	September 28, 2005
Last Update Posted Date	January 22, 2007
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 27, 2005)	Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00227383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
Official Title ICMJE	Not Provided
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.
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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus; Gastroparesis
Intervention ICMJE	Device: Electroacupuncture (device)
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE; (submitted: September 27, 2005)	30
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Taiwan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00227383
Other Study ID Numbers ICMJE	DMR94-IRB-69
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	China Medical University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Chung-Pang Wang, MD China Medical University Hospital
PRS Account	China Medical University Hospital
Verification Date	September 2005
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP