Acupuncture for Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

Official title:

A Randomized, Placebo/Sham-Controlled, Double-Blind Crossover Study to Assess the Efficacy of Acupuncture in the Treatment of Diabetic Gastroparesis.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00470795
• Other study ID #: ACP.GP.07
• Status: Suspended
• Phase: Phase 3
• First received: May 7, 2007
• Last updated: December 14, 2008
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2008
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

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

Locations

Country	Name	City	State
Israel	Dept. of Gastroenterology, Hadassah University Hospital	Jerusalem
Israel	The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GCSI score		3 months	No
Secondary	SF-12 Health Survey Questionnaire; C-13 acetate breath test		3 months	No