Prevention of Corticosteroid-induced Glucose Intolerance

This study is currently recruiting participants.
Verified September 2011 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Motti Muszkat, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00240604
First received: October 16, 2005
Last updated: September 13, 2011
Last verified: September 2011
  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: Double Blind (Subject, Caregiver, 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 Hadassah Medical Organization:

Primary Outcome Measures:
  • plasma glucose concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • corticosteroid treatment

Exclusion Criteria:

  • congestive heart failure pedal edema
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 16, 2005
Last Updated: September 13, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014