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Prevention of Corticosteroid-induced Glucose Intolerance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Motti Muszkat, Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240604
First Posted: October 18, 2005
Last Update Posted: September 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Motti Muszkat, Hadassah Medical Organization
  Purpose
Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Condition Intervention Phase
Glucose Intolerance Drug: Rosiglitazone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Treatment With Rosiglitazone for the Prevention of Glucose Intolerance in Patients Treated With Corticosteroids

Resource links provided by NLM:


Further study details as provided by Motti Muszkat, Hadassah Medical Organization:

Primary Outcome Measures:
  • plasma glucose concentration [ Time Frame: 6 months ]

Estimated Enrollment: 100
Study Start Date: April 2005
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosiglitazone
    4 mg rosiglitazone per day
Detailed Description:
Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • corticosteroid treatment

Exclusion Criteria:

  • congestive heart failure pedal edema
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240604


Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    0097226776095    arik@hadassah.org.il   
Contact: hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Arie BenYehuda, MD Hadassah University Hospital
  More Information

Responsible Party: Motti Muszkat, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00240604     History of Changes
Other Study ID Numbers: 7-29.10.04-HMO-CTIL
First Submitted: October 16, 2005
First Posted: October 18, 2005
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Motti Muszkat, Hadassah Medical Organization:
corticosteroid treatment
inflammatory diseases

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs