Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

Phase 3

• Conditions: Diabetes Mellitus; Gastroparesis

• Registration Number: NCT00227383
• Lead Sponsor: China Medical University Hospital

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 Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Last Update Submitted: 2007-01-19
• Last Update Posted: 2007-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan