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| Sponsored by: |
Rabin Medical Center |
|---|---|
| Information provided by: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00874133 |
Purpose
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:
| Condition | Intervention |
|---|---|
|
Diabetic Gastroparesis |
Procedure: Acupuncture Drug: Motilium |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Motillium: Active Comparator
20 mg motilium thrice daily for 12 weeks.
|
Drug: Motilium
20 mg motilium thrice daily
|
|
Acupuncture: Active Comparator
Acupuncture treatment.
|
Procedure: Acupuncture
Acupuncture treatment for 12 weeks.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ram Dickman, MD | +97239377377 ext 7236 | dickmanr@clalit.org.il |
| Principal Investigator: | Ram Dickman, MD | RMC |
More Information
| Responsible Party: | Rabin Medical Center ( Dr. Ram Dickman ) |
| Study ID Numbers: | 004589 |
| Study First Received: | March 25, 2009 |
| Last Updated: | April 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00874133 History of Changes |
| Health Authority: | Israel: Ethics Commission; Israel: Ministry of Health |
|
Neurotransmitter Agents Gastrointestinal Diseases Antiemetics Paralysis Signs and Symptoms Stomach Diseases Digestive System Diseases |
Domperidone Dopamine Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Gastroparesis |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Dopamine Antagonists Pharmacologic Actions Paralysis Signs and Symptoms |
Stomach Diseases Digestive System Diseases Domperidone Autonomic Agents Therapeutic Uses Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Gastroparesis |
