Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
Primary Purpose
Diabetes Mellitus, Gastroparesis
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Electroacupuncture (device)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, gastroparesis, electroacupuncture
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
Sites / Locations
- China Medical University Hospital
Outcomes
Primary Outcome Measures
Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT00227383
First Posted
September 27, 2005
Last Updated
January 19, 2007
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00227383
Brief Title
Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Gastroparesis
Keywords
Diabetes, gastroparesis, electroacupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Electroacupuncture (device)
Primary Outcome Measure Information:
Title
Solid-phase gastric emptying time and score on Gastroparesis Cardinal Symptom Index(GCSI) at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-Pang Wang, MD
Phone
886-4-22052121
Ext
1431
Email
cpw0509@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Pang Wang, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung-Pang Wang, MD
Phone
886-4-22052121
Ext
1431
First Name & Middle Initial & Last Name & Degree
Chung-Pang Wang
12. IPD Sharing Statement
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Effect of Electroacupuncture in Diabetic Patients With Gastroparesis
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