Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000445673
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
21/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protein turnover and energy expenditure in normal subjects, growth hormone deficiency, acromegaly and Cushing's syndrome
Scientific title
Comparison of protein turnover and energy expenditure in growth hormone deficiency, acromegaly and Cushing's syndrome before and after surgery to normal subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal subjects 557 0
GH deficiency 558 0
Acromegaly 559 0
Cushing's syndrome 560 0
Condition category
Condition code
Metabolic and Endocrine 635 635 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Resection of hormone secreting tumour in subjects with acromegaly and Cushing's syndrome only. the study involves observation of people who have undergone surgery as part of their routine medical care.
Intervention code [1] 340 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 744 0
Whole body leucine turnover
Timepoint [1] 744 0
Secondary outcome [1] 1526 0
Resting energy expenditure, fat oxidation.
Timepoint [1] 1526 0

Eligibility
Key inclusion criteria
Subjects with GH deficiency, acromegaly and Cushing's syndrome and normal volunteers.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer, hepatic and renal failure.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/1995
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 695 0
Government body
Name [1] 695 0
NHMRC
Country [1] 695 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 581 0
None
Name [1] 581 0
Nil
Address [1] 581 0
Country [1] 581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1898 0
St Vincent's Hospital
Ethics committee address [1] 1898 0
Ethics committee country [1] 1898 0
Australia
Date submitted for ethics approval [1] 1898 0
Approval date [1] 1898 0
Ethics approval number [1] 1898 0
Ethics committee name [2] 1899 0
Garvan Institute of Medical Research
Ethics committee address [2] 1899 0
Ethics committee country [2] 1899 0
Australia
Date submitted for ethics approval [2] 1899 0
Approval date [2] 1899 0
Ethics approval number [2] 1899 0

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

Contacts
Principal investigator
Name 35218 0
Address 35218 0
Country 35218 0
Phone 35218 0
Fax 35218 0
Email 35218 0
Contact person for public queries
Name 9529 0
Professor Ken Ho
Address 9529 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 9529 0
Australia
Phone 9529 0
+61 2 92958482
Fax 9529 0
+61 2 92958481
Email 9529 0
k.ho@garvan.org.au
Contact person for scientific queries
Name 457 0
Dr Morton Burt
Address 457 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 457 0
Australia
Phone 457 0
+61 2 92958482
Fax 457 0
+61 2 92958481
Email 457 0
m.burt@garvan.org.au

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.