Acupuncture for Diabetic Gastroparesis

NCT00470795 | Suspended Phase 3

• 1 other identifier: ACP.GP.07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Gastroparesis

Keywords

diabetes; gastroparesis; acupuncture; symptoms; gastric emptying

Outcome Measures

Primary Outcomes (1)

• GCSI score

  3 months

Secondary Outcomes (1)

• SF-12 Health Survey Questionnaire; C-13 acetate breath test

  3 months

Study Arms (2)

A

EXPERIMENTAL

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

Other: Acupuncture

B

PLACEBO COMPARATOR

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

Procedure: placebo/sham acupuncture

Interventions

Acupuncture 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)

A

placebo/sham acupuncture PROCEDURE

acupuncture at sham points without skin penetration

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older;
• Controlled diabetes (\<250 mg/dL);
• Moderate gastroparesis (GCSI \> 2.50);
• Ability to comply with study protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (2)

The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Dept. of Gastroenterology, Hadassah University Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Noah Samuels, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

• Joseph Lysy, M.D.

  Hadassah University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 8, 2007
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 16, 2008

Record last verified: 2008-12

Locations

IL (2)