Acupuncture for Diabetic Gastroparesis

Sponsor

Shaare Zedek Medical Center (Other)

Overall Status

Suspended

CT.gov ID

NCT00470795

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, 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.

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

GCSI score [3 months]

Secondary Outcome Measures

SF-12 Health Survey Questionnaire; C-13 acetate breath test [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center	Jerusalem		Israel	91031
2	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