Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000540415
Ethics application status
Approved
Date submitted
19/10/2007
Date registered
22/10/2007
Date last updated
23/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of fasting glucose and oral glucose tolerance testing to screen for diabetes mellitus in subjects on long-term glucocorticoid therapy
Scientific title
Comparison of fasting glucose and oral glucose tolerance testing to screen for diabetes mellitus in subjects on long-term glucocorticoid therapy
Secondary ID [1] 287964 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of diabetes in subjects receiving long-term glucocorticoid therapy 2480 0
Condition category
Condition code
Metabolic and Endocrine 2581 2581 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Oral glucose tolerance test: This involves a blood test to measure plasma glucose fasting and 2 hours after a 75 g glucose drink. The test takes two hours.
Intervention code [1] 2220 0
Diagnosis / Prognosis
Comparator / control treatment
Subjects with rheumatologic disease not on glucocorticoids
Control group
Historical

Outcomes
Primary outcome [1] 3489 0
Sensitivity of fasting glucose to determine diabetes
Timepoint [1] 3489 0
At the end of the 12 month study period.
Secondary outcome [1] 5825 0
Prevalence of diabetes
Timepoint [1] 5825 0
At the end of the 12 month study period.

Eligibility
Key inclusion criteria
Long-term glucocorticoid therapy (> 6 months)
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes mellitus
Active inflammatory disease (defined as clinical evidence of active synovitis, elevated C-reactive protein (CRP) or recent intensification of immunosuppressive therapy)
Significant hepatic (AST or ALT > 3 times upper limit of normal) or renal (serum creatinine > 200µmol/L) dysfunction

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2007
Actual
22/10/2007
Date of last participant enrolment
Anticipated
Actual
29/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2736 0
Hospital
Name [1] 2736 0
Foundation Daw Park
Country [1] 2736 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daw Rd
Daw Park 5041 SA
Country
Australia
Secondary sponsor category [1] 2471 0
None
Name [1] 2471 0
Address [1] 2471 0
Country [1] 2471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4652 0
Repatriation General Hospital
Ethics committee address [1] 4652 0
Ethics committee country [1] 4652 0
Australia
Date submitted for ethics approval [1] 4652 0
Approval date [1] 4652 0
23/07/2007
Ethics approval number [1] 4652 0
RGH 36/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28131 0
A/Prof Morton Burt
Address 28131 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd, Daw Park SA 5041
Country 28131 0
Australia
Phone 28131 0
61882751094
Fax 28131 0
Email 28131 0
[email protected]
Contact person for public queries
Name 11288 0
Dr Morton Burt
Address 11288 0
Repatriation General Hospital
Daw Rd
Daw Park 5041 SA
Country 11288 0
Australia
Phone 11288 0
08 82967666
Fax 11288 0
Email 11288 0
[email protected]
Contact person for scientific queries
Name 2216 0
Dr Morton Burt
Address 2216 0
Repatriation General Hospital
Daw Rd
Daw Park 5041 SA
Country 2216 0
Australia
Phone 2216 0
08 82967666
Fax 2216 0
Email 2216 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.