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
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis
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.
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
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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