NCT00240604

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

8.7 years

First QC Date

October 16, 2005

Last Update Submit

September 13, 2011

Conditions

Glucose Intolerance

Keywords

corticosteroid treatmentinflammatory diseases

Outcome Measures

Primary Outcomes (1)

  • plasma glucose concentration

    6 months

Interventions

RosiglitazoneDRUG

4 mg rosiglitazone per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • corticosteroid treatment

You may not qualify if:

  • congestive heart failure pedal edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Arie BenYehuda, MD

    Hadassah University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 16, 2005

First Posted

October 18, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2013

Study Completion

October 1, 2015

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

IL(1)