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

NCT00874133 | Terminated DMC

• 1 other identifier: 004589
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
2. 2.To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
3. 3.To determine the effect of treatment with motilium or acupuncture on glycemic control.
4. 4.To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Level of improvement of gastric emptying rate

  6 months

Secondary Outcomes (1)

• Improvement in blood glucose levels

  6 months

Study Arms (2)

Motillium

ACTIVE COMPARATOR

20 mg motilium thrice daily for 12 weeks.

Drug: Motilium

Acupuncture

ACTIVE COMPARATOR

Acupuncture treatment.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Acupuncture treatment for 12 weeks.

Also known as: Domperidone

Acupuncture

Motilium DRUG

20 mg motilium thrice daily

Also known as: Domperidone

Motillium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Interventions

Acupuncture Therapy; Domperidone

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ram Dickman, MD

  RMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: April 2, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 6, 2013

Record last verified: 2013-12