Trial Review

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
ACTRN12605000444684
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
How is protein metabolism perturbed by long-term glucocorticoid use?
Scientific title
How is protein metabolism perturbed by long-term glucocorticoid use in subjects with polymyalgia rheumatica?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyalgia rheumatica (PMR) on long-term glucocorticoids 556 0
Condition category
Condition code
Musculoskeletal 634 634 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil
Intervention code [1] 338 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 743 0
Whole body leucine turnover
Timepoint [1] 743 0
Secondary outcome [1] 1525 0
Insulin sensitivity, resting energy expenditure and fat oxidation.
Timepoint [1] 1525 0

Eligibility
Key inclusion criteria
Receiving long-term low dose glucocorticoids for PMR. No evidence of active inflammatory state.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes, cancer, hepatic and renal failure.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 693 0
Government body
Name [1] 693 0
NHMRC
Country [1] 693 0
Australia
Funding source category [2] 694 0
Hospital
Name [2] 694 0
St Vincent's Clinic
Country [2] 694 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 580 0
None
Name [1] 580 0
Nil
Address [1] 580 0
Country [1] 580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1896 0
St Vincent's Hospital
Ethics committee address [1] 1896 0
Ethics committee country [1] 1896 0
Australia
Date submitted for ethics approval [1] 1896 0
Approval date [1] 1896 0
Ethics approval number [1] 1896 0
Ethics committee name [2] 1897 0
Garvan Institute of Medical Research
Ethics committee address [2] 1897 0
Ethics committee country [2] 1897 0
Australia
Date submitted for ethics approval [2] 1897 0
Approval date [2] 1897 0
Ethics approval number [2] 1897 0

Summary
Brief summary
Long-term glucocorticoid use causes substantial morbidity from protein loss. The aim was to determine how protein metabolism was perturbed in long-term glucocorticoid users.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36257 0
Address 36257 0
Country 36257 0
Phone 36257 0
Fax 36257 0
Email 36257 0
Contact person for public queries
Name 9527 0
Professor Ken Ho
Address 9527 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 9527 0
Australia
Phone 9527 0
+61 2 92958482
Fax 9527 0
+61 2 92958481
Email 9527 0
[email protected]
Contact person for scientific queries
Name 455 0
Dr Morton Burt
Address 455 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 455 0
Australia
Phone 455 0
+61 2 92958484
Fax 455 0
+61 2 92958481
Email 455 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.