ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

Saline injection

Control group

Placebo

Outcomes

Primary outcome [1]

Anaerobic Capacity was assessed by a 30-second all out sprint on a cycle ergometer during the Wingate test

Timepoint [1]

At baseline and at 1, 2 and 8 months

Primary outcome [2]

Aerobic capacity was measured as VO2max during an incremental exercise test on a cycle ergometer

Timepoint [2]

At baseline and at 1, 2 and 8 months

Secondary outcome [1]

Chair-stand test. This measures the number of chair-stand repetitions during 30 seconds

Timepoint [1]

At baseline and at 1, 2 and 8 months

Secondary outcome [2]

Stair-climb test. This measures the time taken to climb 4 flights of stairs.

Timepoint [2]

At baseline and at 1, 2 and 8 months

Secondary outcome [3]

7-day Pedometry. This measures the number of step counts over 7 days by a pedometer.

Timepoint [3]

At baseline and at 1, 2 and 8 months

Secondary outcome [4]

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]

At 1, 2 and 8 months

Secondary outcome [5]

Body composition assessed by DEXA scan

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Princess Alexandra Hospital Research Foundation

Address [1]

199 Ipswich Rd, Brisbane, QLD 4102

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Alexandra Hospital

Address

199 Ipswich Rd, Brisbane, QLD 4102

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Novo Nordisk

Address [1]

Level 3
21 Solent Circuit
BAULKHAM HILLS NSW 2153
AUSTRALIA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Level 7, Translational Research Institute, 37 Kent Street, Brisbane, QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/04/2012

Ethics approval number [1]

HREC/12/QPAH/126

Summary

Brief summary

Aerobic energy powers endurance exercises e.g. jogging, long distance running etc. and it is used as a measure of fitness. On the other hand, initiation of any activity (e.g. rushing for a bus, climbing stairs) relies on anaerobic energy that is provided by preformed energy in form of phosphocreatine and glycolysis (breakdown of glucose) that occurs in absence of oxygen. Hence, individuals with inadequate anaerobic energy levels usually struggle to carry out their activities of daily living and suffer from chronic fatigue. What regulates the Anaerobic Energy System (AES) is not well studied and the factors that enhance AES apart from physical training are not known.

Adults with Growth Hormone Deficiency (GHD) typically suffer from chronic fatigue and loss of vitality, symptoms suggesting impairment of the AES. These symptoms improve with GH replacement. However, the mechanisms underlying the symptomatology and how it is improved are poorly understood.

New research shows that GH plays a vital role in energy provision. A recent study showed that administration to healthy subjects with GH enhanced sprinting, which is a marker of anaerobic capacity. However, GH did not improve any other measures of physical performance. Another research studied the effects of GH treatment in GHD subjects at a cellular level and found that GH favored the use of glucose (anaerobic glycolysis) over fat as a fuel for energy provision in muscle cells. These studies indicate that GH may have a positive role in regulating the AES.

The main aims of this study are to investigate the effects of GH on anaerobic capacity and genes governing energy metabolism in skeletal muscle, and study the relationship between the AES and physical function.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ken Ho

Address

Level 7, Translational Research Institute, 37 Kent Street, Brisbane, QLD 4102

Country

Australia

Phone

+61 7 3443 8065

Fax

k.ho@uq.edu.au

Contact person for public queries

Name

Viral Chikani

Address

Dept of Diabetes and Endocrinology,
Princess Alexandra Hospital
199 Ipswich Rd, Brisbane, QLD 4102

Country

Australia

Phone

+61 7 3176 2111

Fax

v.chikani@uq.edu.au

Contact person for scientific queries

Name

Ken Ho

Address

Level 7, Translational Research Institute, 37 Kent Street, Brisbane, QLD 4102

Country

Australia

Phone

+61 7 3443 8065

Fax

k.ho@uq.edu.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

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