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

Primary Purpose

Diabetic Gastroparesis

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Motilium
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Motillium

    Acupuncture

    Arm Description

    20 mg motilium thrice daily for 12 weeks.

    Acupuncture treatment.

    Outcomes

    Primary Outcome Measures

    Level of improvement of gastric emptying rate

    Secondary Outcome Measures

    Improvement in blood glucose levels

    Full Information

    First Posted
    March 25, 2009
    Last Updated
    December 5, 2013
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00874133
    Brief Title
    The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
    Official Title
    The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    Completed due to low number of eligible patients
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Gastroparesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Motillium
    Arm Type
    Active Comparator
    Arm Description
    20 mg motilium thrice daily for 12 weeks.
    Arm Title
    Acupuncture
    Arm Type
    Active Comparator
    Arm Description
    Acupuncture treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Other Intervention Name(s)
    Domperidone
    Intervention Description
    Acupuncture treatment for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Motilium
    Other Intervention Name(s)
    Domperidone
    Intervention Description
    20 mg motilium thrice daily
    Primary Outcome Measure Information:
    Title
    Level of improvement of gastric emptying rate
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Improvement in blood glucose levels
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ram Dickman, MD
    Organizational Affiliation
    RMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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