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

NCT ID: NCT00874133

Last Updated: 2013-12-06

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

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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This is a randomized, comparative, pilot study, which will compare two treatments: acupuncture treatment vs. treatment with motilium in 30 diabetic patients with impaired glucose control and gastroparesis.

All patients who meet inclusion criteria will undergo gastric scintigraphy and upper endoscopy to assess the presence of gastroparesis and to rule out gastric outlet obstruction. At baseline, all enrolled patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI), the Quality of life questionnaire (SF-36). Subsequently, patients will be randomized to 20 mg motilium thrice daily and after 1 month wash-out period to acupuncture treatment, each treatment will last 12 weeks.

After treatment, patients will undergo a second gastric scintigraphy and will complete the GCSI and the SF-36.

Fasting blood glucose concentrations and HbA1c levels will be determined at the beginning and at the end of the study and at 6 months later as well.

End Points:

Primary: Level of improvement of gastric emptying rate, and improvement in blood glucose levels at the end of treatment, in comparison with tests before treatment.

Secondary: Level of improvement in scores of severity of gastroparesis related symptoms, with quality of life indicators, in comparison with tests before treatment; also, the number of visits to family doctors/diabetic clinics/emergency rooms, as well as use of the medications resulting from diabetic complications will be investigated.

Conditions

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Diabetic Gastroparesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motillium

20 mg motilium thrice daily for 12 weeks.

Group Type ACTIVE_COMPARATOR

Motilium

Intervention Type DRUG

20 mg motilium thrice daily

Acupuncture

Acupuncture treatment.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

Acupuncture treatment for 12 weeks.

Interventions

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Acupuncture

Acupuncture treatment for 12 weeks.

Intervention Type PROCEDURE

Motilium

20 mg motilium thrice daily

Intervention Type DRUG

Other Intervention Names

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Domperidone Domperidone

Eligibility Criteria

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Inclusion Criteria

* Age: 18-80,
* Diabetic patients of over 10 years duration with impaired glucose control, after at least 6 months of accepted treatment in a Diabetes Clinic by the study staff before inclusion in the study, who exhibit symptoms which could signify the possibility of diabetic gastroparesis.

Exclusion Criteria

* Known hyperprolactinemia, systemic or localized neurological disturbances (myopathy, multiple sclerosis, Parkinson's disease, myelopathy), with the exception of diabetic neuropathy, past stomach or esophagus surgery, pregnancy, inability to sign Informed Consent, fear of acupuncture, limb amputation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dickman ram

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ram Dickman, MD

Role: PRINCIPAL_INVESTIGATOR

RMC

Other Identifiers

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004589

Identifier Type: -

Identifier Source: org_study_id