Acupuncture for Diabetic Gastroparesis

This study has suspended participant recruitment.
(Protocol to be re-designed (primary outome still GCSI))
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00470795
First received: May 7, 2007
Last updated: December 14, 2008
Last verified: December 2008
  Purpose

Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful effects. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, including those involving the gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe treatment for diabetic gastroparesis using a randomized, double-blind, placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and validated instrument for quantifying symptoms in these patients. As a secondary outcome we will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short Form Health Survey. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.

Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill the inclusion criteria (and none of the exclusion criteria) will be eligible to participate in the study. On induction, participants will fill out the GCSI questionnaire and SF-36 survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form, as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. At the end of the second treatment regimen all participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a C13-acetate breath test. At the end of the second treatment regimen participants will again fill out a Validation of Blinding Questionnaire.


Condition Intervention Phase
Diabetic Gastroparesis
Other: Acupuncture
Procedure: placebo/sham acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo/Sham-Controlled, Double-Blind Crossover Study to Assess the Efficacy of Acupuncture in the Treatment of Diabetic Gastroparesis.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • GCSI score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12 Health Survey Questionnaire; C-13 acetate breath test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Acupuncture - 2 treatments weekly, 4 weeks (8 treatment)
Other: Acupuncture
acupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment)
Placebo Comparator: B
Placebo/sham treatment; twice weekly for 4 weeks (total 8 treatments)
Procedure: placebo/sham acupuncture
acupuncture at sham points without skin penetration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older;
  • Controlled diabetes (<250 mg/dL);
  • Moderate gastroparesis (GCSI > 2.50);
  • Ability to comply with study protocol

Exclusion Criteria:

  • Past experience with acupuncture;
  • History of gastric surgery, intrapyloric botulinum toxin, gastric pacemaker;
  • Uncontrolled diabetes or evidence of diabetic ketoacidosis;
  • Malabsorptive syndrome, liver or pulmonary disease;
  • Pregnancy or fertility treatments;
  • Overt psychopathology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470795

Locations
Israel
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Dept. of Gastroenterology, Hadassah University Hospital
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Noah Samuels, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigator: Joseph Lysy, M.D. Hadassah University Hospital
  More Information

No publications provided

Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00470795     History of Changes
Other Study ID Numbers: ACP.GP.07
Study First Received: May 7, 2007
Last Updated: December 14, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
diabetes
gastroparesis
acupuncture
symptoms
gastric emptying

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014