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The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis

NCT00874133 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-12-06

No results posted yet for this study

Summary

Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.Treatment with acupuncture has been described as effective in improvement of symptoms in patients with gastroparesis in a number of patient series. However, this treatment approach has not been tested by means of a controlled randomized clinical study, and neither has the connection between improvement of symptoms and the anatomical-physiological effect of the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice daily) as compared to acupuncture treatment on the following subjective and objective parameters of 30 patients with diabetic gastroparesis and impaired glucose control:

1. To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
2. To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
3. To determine the effect of treatment with motilium or acupuncture on glycemic control.
4. To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).

Conditions

  • Diabetic Gastroparesis

Interventions

PROCEDURE

Acupuncture

Acupuncture treatment for 12 weeks.

DRUG

Motilium

20 mg motilium thrice daily

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Ram Dickman, MD · RMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874133 on ClinicalTrials.gov