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

This study has been terminated.
(Completed due to low number of eligible patients)
Sponsor:
Information provided by (Responsible Party):
dickman ram, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00874133
First received: March 25, 2009
Last updated: December 5, 2013
Last verified: December 2013
  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:

  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).

Condition Intervention
Diabetic Gastroparesis
Procedure: Acupuncture
Drug: Motilium

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Level of improvement of gastric emptying rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in blood glucose levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Motillium
20 mg motilium thrice daily for 12 weeks.
Drug: Motilium
20 mg motilium thrice daily
Other Name: Domperidone
Active Comparator: Acupuncture
Acupuncture treatment.
Procedure: Acupuncture
Acupuncture treatment for 12 weeks.
Other Name: Domperidone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874133

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ram Dickman, MD RMC
  More Information

No publications provided

Responsible Party: dickman ram, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00874133     History of Changes
Other Study ID Numbers: 004589
Study First Received: March 25, 2009
Last Updated: December 5, 2013
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases
Domperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014