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
ACTRN12605000443695
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
Impact of short-term low dose glucocorticoids on protein metabolism
Scientific title
Impact of short-term low dose glucocorticoids on protein metabolism in normal subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers 555 0
Condition category
Condition code
Metabolic and Endocrine 633 633 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prednisolone 10mg/d for one week
Intervention code [1] 337 0
Treatment: Drugs
Comparator / control treatment
Prednisolone 5mg/d for one week
Control group
Dose comparison

Outcomes
Primary outcome [1] 742 0
Whole body leucine turnover before and after low dose glucocorticoids
Timepoint [1] 742 0
Before and after low dose glucocorticoids
Secondary outcome [1] 1524 0
Insulin sensitivity, resting energy expenditure and fat oxidation before and after low dose glucocorticoids.
Timepoint [1] 1524 0

Eligibility
Key inclusion criteria
Healthy subjects.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes mellitus, cancer, liver and kidney failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 692 0
Government body
Name [1] 692 0
NHMRC
Country [1] 692 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 579 0
None
Name [1] 579 0
Nil
Address [1] 579 0
Country [1] 579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1894 0
St Vincent's Hospital
Ethics committee address [1] 1894 0
Ethics committee country [1] 1894 0
Australia
Date submitted for ethics approval [1] 1894 0
Approval date [1] 1894 0
Ethics approval number [1] 1894 0
Ethics committee name [2] 1895 0
Garvan Institute of Medical Research
Ethics committee address [2] 1895 0
Ethics committee country [2] 1895 0
Australia
Date submitted for ethics approval [2] 1895 0
Approval date [2] 1895 0
Ethics approval number [2] 1895 0

Summary
Brief summary
The aim of this study is to determine if short-term low dose glucocorticoids alters protein metabolism in a way that results in protein loss. This information will help in the development of therapies that reverse or prevent protein loss in patients requiring long-term glucocorticoids.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35671 0
Address 35671 0
Country 35671 0
Phone 35671 0
Fax 35671 0
Email 35671 0
Contact person for public queries
Name 9526 0
Professor Ken Ho
Address 9526 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 9526 0
Australia
Phone 9526 0
+61 2 92958482
Fax 9526 0
+61 2 92958481
Email 9526 0
[email protected]
Contact person for scientific queries
Name 454 0
Dr Morton Burt
Address 454 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 454 0
Australia
Phone 454 0
+61 2 92958484
Fax 454 0
+61 2 92958481
Email 454 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.