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Acupuncture for Diabetic Gastroparesis

NCT ID: NCT00470795

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Gastroparesis

Keywords

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diabetes gastroparesis acupuncture symptoms gastric emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Acupuncture - 2 treatments weekly, 4 weeks (8 treatment)

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

acupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment)

B

Placebo/sham treatment; twice weekly for 4 weeks (total 8 treatments)

Group Type PLACEBO_COMPARATOR

placebo/sham acupuncture

Intervention Type PROCEDURE

acupuncture at sham points without skin penetration

Interventions

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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)

Intervention Type OTHER

placebo/sham acupuncture

acupuncture at sham points without skin penetration

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center

Principal Investigators

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Noah Samuels, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Joseph Lysy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital

Locations

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The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Dept. of Gastroenterology, Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ACP.GP.07

Identifier Type: -

Identifier Source: org_study_id