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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
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, gastroparesis, electroacupuncture

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 27, 2005
Last Updated
January 19, 2007
Sponsor
China Medical University Hospital
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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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