Acupuncture for Diabetic Gastroparesis

December 14, 2008 updated by: Shaare Zedek Medical Center

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Dept. of Gastroenterology, Hadassah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GCSI score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-12 Health Survey Questionnaire; C-13 acetate breath test
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2008

Last Update Submitted That Met QC Criteria

December 14, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP.GP.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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