Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000046505
Ethics application status
Approved
Date submitted
1/01/2015
Date registered
21/01/2015
Date last updated
12/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of growth hormone on muscle function
Scientific title
Effect of growth hormone (GH) on anaerobic capacity: a double blind placebo-controlled study in growth hormone deficient (GHD) adults
Secondary ID [1] 285887 0
nil
Universal Trial Number (UTN)
U1111-1127-1004
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth hormone deficiency 293810 0
Condition category
Condition code
Metabolic and Endocrine 294111 294111 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2-month double-blind placebo controlled GH treatment (0.5mg/d) study with a crossover at 1 month, followed by an open-label active treatment phase (0.5mg/d) for 6 months in 20 GHD adults. There is no 'wash out' period between treatment periods. 4 weeks of Placebo treatment is adequate to wash out any GH effect on Wingate performance based on pilot data from our laboratory. GH is administered via subcutaneous injection. Adherence to the intervention will be assessed by counting empty drug vials and measuring plasma IGF1 levels.
Intervention code [1] 290869 0
Treatment: Drugs
Comparator / control treatment
Saline injection
Control group
Placebo

Outcomes
Primary outcome [1] 293908 0
Anaerobic Capacity was assessed by a 30-second all out sprint on a cycle ergometer during the Wingate test
Timepoint [1] 293908 0
At baseline and at 1, 2 and 8 months
Primary outcome [2] 293909 0
Aerobic capacity was measured as VO2max during an incremental exercise test on a cycle ergometer
Timepoint [2] 293909 0
At baseline and at 1, 2 and 8 months
Secondary outcome [1] 312132 0
Chair-stand test. This measures the number of chair-stand repetitions during 30 seconds
Timepoint [1] 312132 0
At baseline and at 1, 2 and 8 months
Secondary outcome [2] 312133 0
Stair-climb test. This measures the time taken to climb 4 flights of stairs.
Timepoint [2] 312133 0
At baseline and at 1, 2 and 8 months
Secondary outcome [3] 312134 0
7-day Pedometry. This measures the number of step counts over 7 days by a pedometer.
Timepoint [3] 312134 0
At baseline and at 1, 2 and 8 months
Secondary outcome [4] 312135 0
Metabolic gene expression in skeletal muscle.

This will be undertaken by studying genes regulating energy metabolism by microarray analysis of biopsies of quadriceps muscle
Timepoint [4] 312135 0
At 1, 2 and 8 months
Secondary outcome [5] 312137 0
Body composition assessed by DEXA scan
Timepoint [5] 312137 0
At baseline and at 1, 2 and 8 months

Eligibility
Key inclusion criteria
Growth hormone deficiency (diagnosed as per internationally accepted criteria)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cardiac, respiratory, renal, liver or neurological disease
2. Pregnancy
3. Malignancy
4. Inability to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GHD adults are recruited from outpatient clinics at the Princess Alexandra Hospital.
Randomisation codes are kept in an opaque, sealed envelope. Subjects are allocated to GH or placebo by a member of the team who is not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
20 random numbers are generated by a computer assigning a specific treatment order to each number. These numbers are randomly allocated to 20 subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the double blind placebo controlled crossover study, the significance of differences between treatment groups will be evaluated by repeated measures ANOVA. These data will be analyzed for a carryover effect using mixed model analysis looking at the effect of the interaction between treatment order and treatment itself on the outcome measures.

In the 6-month open label study, the effects of GH on outcome measures will be analysed using paired t-test.

Associations will be analysed by simple linear regressions. Independent predictors of outcome measures will be analysed by multiple regression analysis.
The sample size is based on anaerobic capacity data from our studies in athletes and aerobic performance data from the literature. A sample size of 15 is required to show a 5% improvement in Wingate power and 18 for a 15% improvement in VO2max at a 0.05 level significance with 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2013
Actual
19/02/2013
Date of last participant enrolment
Anticipated
9/04/2014
Actual
9/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3296 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 9080 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 290470 0
Charities/Societies/Foundations
Name [1] 290470 0
Princess Alexandra Hospital Research Foundation
Country [1] 290470 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd, Brisbane, QLD 4102
Country
Australia
Secondary sponsor category [1] 289172 0
Commercial sector/Industry
Name [1] 289172 0
Novo Nordisk
Address [1] 289172 0
Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153
AUSTRALIA
Country [1] 289172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292139 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 292139 0
Ethics committee country [1] 292139 0
Australia
Date submitted for ethics approval [1] 292139 0
Approval date [1] 292139 0
03/04/2012
Ethics approval number [1] 292139 0
HREC/12/QPAH/126

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

Contacts
Principal investigator
Name 53698 0
Prof Ken Ho
Address 53698 0
Level 7, Translational Research Institute, 37 Kent Street, Brisbane, QLD 4102
Country 53698 0
Australia
Phone 53698 0
+61 7 3443 8065
Fax 53698 0
Email 53698 0
[email protected]
Contact person for public queries
Name 53699 0
Viral Chikani
Address 53699 0
Dept of Diabetes and Endocrinology,
Princess Alexandra Hospital
199 Ipswich Rd, Brisbane, QLD 4102
Country 53699 0
Australia
Phone 53699 0
+61 7 3176 2111
Fax 53699 0
Email 53699 0
[email protected]
Contact person for scientific queries
Name 53700 0
Ken Ho
Address 53700 0
Level 7, Translational Research Institute, 37 Kent Street, Brisbane, QLD 4102
Country 53700 0
Australia
Phone 53700 0
+61 7 3443 8065
Fax 53700 0
Email 53700 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.