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Prevention of Corticosteroid-induced Glucose Intolerance

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ClinicalTrials.gov Identifier: NCT00240604
Recruitment Status : Unknown
Verified September 2011 by Motti Muszkat, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : October 18, 2005
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Glucose Intolerance Drug: Rosiglitazone Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : April 2005
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Rosiglitazone
    4 mg rosiglitazone per day

Outcome Measures

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

Eligibility Criteria

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 Posted: October 18, 2005    Key Record Dates
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