Acupuncture for Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470795
Recruitment Status : Suspended (Protocol to be re-designed (primary outome still GCSI))
First Posted : May 8, 2007
Last Update Posted : December 16, 2008
Information provided by:
Shaare Zedek Medical Center

May 7, 2007
May 8, 2007
December 16, 2008
June 2009
June 2010   (Final data collection date for primary outcome measure)
GCSI score [ Time Frame: 3 months ]
Gastroparesis Cardinal Symptom Index
Complete list of historical versions of study NCT00470795 on Archive Site
SF-12 Health Survey Questionnaire; C-13 acetate breath test [ Time Frame: 3 months ]
SF-12 Health Survey Questionnaire; C-13 acetate breath test
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Acupuncture for Diabetic Gastroparesis
A Randomized, Placebo/Sham-Controlled, Double-Blind Crossover Study to Assess the Efficacy of Acupuncture in the Treatment of Diabetic Gastroparesis.

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.

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Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Gastroparesis
  • 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)
  • Procedure: placebo/sham acupuncture
    acupuncture at sham points without skin penetration
  • Experimental: A
    Acupuncture - 2 treatments weekly, 4 weeks (8 treatment)
    Intervention: Other: Acupuncture
  • Placebo Comparator: B
    Placebo/sham treatment; twice weekly for 4 weeks (total 8 treatments)
    Intervention: Procedure: placebo/sham acupuncture
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Dr. Noah Samuels, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Noah Samuels, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigator: Joseph Lysy, M.D. Hadassah University Hospital
Shaare Zedek Medical Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP