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 III

Further study details as provided by China Medical University Hospital:

Primary Outcomes: Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Type 2 diabetes
• Dyspetic sympotms 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00227383

Chung-Pang Wang, MD      886-4-22052121  Ext. 1431    cpw0509@yahoo.com.tw

Taiwan
      China Medical University Hospital, Taichung,  404,  Taiwan

Study chairs or principal investigators

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

Study ID Numbers:  DMR94-IRB-69
Last Updated:  December 8, 2005
Record first received:  September 27, 2005
ClinicalTrials.gov Identifier:  NCT00227383
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10