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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Domperidone

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.