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

May 7, 2007
December 14, 2008
June 2009
June 2010   (final data collection date for primary outcome measure)
GCSI score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Gastroparesis Cardinal Symptom Index
Complete list of historical versions of study NCT00470795 on ClinicalTrials.gov Archive Site
SF-12 Health Survey Questionnaire; C-13 acetate breath test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
SF-12 Health Survey Questionnaire; C-13 acetate breath test
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00470795
ACP.GP.07
No
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