Trial Review

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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
Daw Rd
Daw Park 5041 SA
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
The primary purpose of this study is to determine the prevalence of diabetes in subjects on long-term glucocorticoid (steroid) therapy and the best way to diagnose diabetes in this patient group.
Trial website
Trial related presentations / publications
Burt MG, Willenberg VM, Petersons CJ, Smith MD, Ahern MJ, Stranks SN. Screening for diabetes in patients with inflammatory rheumatologic disease administered long-term prednisolone: A cross-sectional study. Rheumatology 2012;51:1112-1119
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
A/Prof 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
A/Prof 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.