Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

This study is not yet open for participant recruitment.

Verified by China Medical University Hospital, September 2005

First Received: September 27, 2005 Last Updated: January 19, 2007 History of Changes

Sponsored by:	China Medical University Hospital
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00227383

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227383

Contacts

Contact: Chung-Pang Wang, MD

886-4-22052121 ext 1431

cpw0509@yahoo.com.tw

Locations

Taiwan
China Medical University Hospital
Taichung, Taiwan, 404

Sponsors and Collaborators

China Medical University Hospital

Investigators

Study Chair:

Chung-Pang Wang, MD

China Medical University Hospital

More Information

No publications provided

Study ID Numbers:	DMR94-IRB-69
Study First Received:	September 27, 2005
Last Updated:	January 19, 2007
ClinicalTrials.gov Identifier:	NCT00227383 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University Hospital:

Diabetes
gastroparesis
electroacupuncture

Study placed in the following topic categories:

Metabolic Diseases
Gastrointestinal Diseases
Diabetes Mellitus
Endocrine System Diseases
Paralysis
Signs and Symptoms
Stomach Diseases

Digestive System Diseases
Neurologic Manifestations
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Gastroparesis

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Metabolic Diseases
Gastrointestinal Diseases

Diabetes Mellitus
Neurologic Manifestations
Endocrine System Diseases
Glucose Metabolism Disorders
Gastroparesis

ClinicalTrials.gov processed this record on September 11, 2009