Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

• ClinicalTrials.gov Identifier: NCT00227383
• Recruitment Status: Unknown
• First Posted: September 28, 2005
• Last Update Posted: January 22, 2007
• Sponsor: China Medical University Hospital
• Information provided by: China Medical University Hospital

Tracking Information

• First Submitted Date: September 27, 2005
• First Posted Date: September 28, 2005
• Last Update Posted Date: January 22, 2007
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 27, 2005): Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment

Condition

• Diabetes Mellitus
• Gastroparesis

• Intervention: Device: Electroacupuncture (device)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: September 27, 2005): 30
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00227383
• Other Study ID Numbers: 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: China Medical University Hospital
• Collaborators: Not Provided

Investigators

• Study Chair: Chung-Pang Wang, MD; China Medical University Hospital

• PRS Account: China Medical University Hospital
• Verification Date: September 2005