An interventional study of Acupuncture and Motilium in Diabetic Gastroparesis, sponsored by Rabin Medical Center. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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:
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.
Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
20 mg motilium thrice daily for 12 weeks.
Drug: Motilium
Acupuncture treatment.
Procedure: Acupuncture
Acupuncture treatment for 12 weeks.
Also known as: Domperidone
20 mg motilium thrice daily
Also known as: Domperidone
Level of improvement of gastric emptying rate
Time frame: 6 months
Improvement in blood glucose levels
Time frame: 6 months
No study locations are listed for this record.
The record gives a start of Mar 2009, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Domperidone