Status:
COMPLETED
Transcutaneous Electroacupuncture for Gastroparesis
Lead Sponsor:
Transtimulation Research, Inc
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
University of Mississippi Medical Center
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of patients with ...
Eligibility Criteria
Inclusion
- At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms);
- Abnormal gastric emptying defined as more than 10% of gastric retention at 4 hrs after a standard solid meal (see below) during the past 3 months;
- Males and females between ages 18-65 yrs;
- Subjects with high probability for compliance and completion of the study.
- Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
- Diabetes.
Exclusion
- 1\) History of gastric bezoar or diverticulitis. 2) Severe daily abdominal pain requiring medications for relief. 3) Severe weight loss, greater than 10 lbs over the preceding 2 months. 4) Uncontrolled diabetes with a hemoglobin A1C greater than 10. 5) Excessively delayed gastric emptying time: more than 90% of a standard meal retained after 2 hours. 6) Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery. 7) Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy; 8) Surgery within the past 3 months. 9) Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test). 10) Those who have been treated with acupuncture or those who are familiar with acupuncture points. 11). Allergic to Ensure, strawberry jam and eggs.
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Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01469286
Start Date
March 1 2010
End Date
July 1 2012
Last Update
May 1 2017
Active Locations (2)
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1
University of Mississippi
Jackson, Mississippi, United States, 39214
2
Texas tech university health science center
El Paso, Texas, United States, 79905