Back to resultsPrevention of Corticosteroid-induced Glucose Intolerance
Primary Purpose
Glucose Intolerance
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance focused on measuring corticosteroid treatment, inflammatory diseases
Eligibility Criteria
Inclusion Criteria: corticosteroid treatment Exclusion Criteria: congestive heart failure pedal edema
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Outcomes
Primary Outcome Measures
plasma glucose concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT00240604
First Posted
October 16, 2005
Last Updated
September 13, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00240604
Brief Title
Prevention of Corticosteroid-induced Glucose Intolerance
Official Title
Treatment With Rosiglitazone for the Prevention of Glucose Intolerance in Patients Treated With Corticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance
Keywords
corticosteroid treatment, inflammatory diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
4 mg rosiglitazone per day
Primary Outcome Measure Information:
Title
plasma glucose concentration
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
corticosteroid treatment
Exclusion Criteria:
congestive heart failure pedal edema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie BenYehuda, MD
Organizational Affiliation
Hadassah University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
0097226776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
hadas Lemberg, PhD
Phone
0097226777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Mordechai Muszkat, MD
12. IPD Sharing Statement
Learn more about this trial
Prevention of Corticosteroid-induced Glucose Intolerance
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