Diabetic Gastroparesis Clinical Trial
Official title:
The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis
Verified date | December 2013 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 8 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of improvement of gastric emptying rate | 6 months | ||
Secondary | Improvement in blood glucose levels | 6 months |
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