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Trial registered on ANZCTR


Registration number
ACTRN12613000059763
Ethics application status
Not yet submitted
Date submitted
15/01/2013
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of FTO Gene Variants on Metabolic Flexibility and Training Adaptations following a 12 Week High Intensity Exercise Intervention
Scientific title
The role of FTO Gene Variants on Metabolic Flexibility and Training Adaptations in Relatively Healthy Males following a 12 Week High Intensity Exercise Intervention
Secondary ID [1] 281776 0
Nil
Universal Trial Number (UTN)
U1111-1138-5521
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Flexibility
 288093 0
Overweight and Obesity
 288094 0
Condition category
Condition code
Human Genetics and Inherited Disorders 288465 288465 0 0
Other human genetics and inherited disorders
Physical Medicine / Rehabilitation 288466 288466 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 288467 288467 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to submit to a 12 week exercise training intervention. Thirty six (36) training sessions will be conducted in total over the 12 week period. This intervention will involve participants cycling at 150% VO2max for 20 seconds with 40 seconds passive recovery per minute during each session. The frequency and duration of sessions will be incremented in 4 x 3 week blocks (weeks 1-3, 2 x 20 minutes per week; weeks 4-6, 3 x 20 minutes per week; weeks 7-9, 3 x 30 minutes per week; weeks 10-12, 4 x 30 minutes per week).

Prior to and following the 12 week exercise training intervention participants will be asked to perform exercise tests during two testing sessions (total of four testing sessions). One exercise test will involve a single bout of cycle ergometer exercise at 80% (HI) VO2max for 38 minutes which expends ~400 kcal. This is a crossover study with the order of the exercise tests being randomised. The second test will occur a minimum of 2 days following the commencement of the first exercise test (maximum of up to 1 week). The second exercise test will involve a single bout of cycle ergometer exercise at 40% (LO) VO2max for 70 minutes which expends ~400 kcal. This washout period will be based on participants and workplace availability.
Intervention code [1] 286321 0
Prevention
Intervention code [2] 286322 0
Treatment: Other
Intervention code [3] 286323 0
Behaviour
Comparator / control treatment
Participants with the FTO rs9939609 risk allele (A) and participants with two FTO rs9939609 wild type alleles (TT) will be there own controls (crossover study). Participants will be asked to perform a single bout of cycle ergometer exercise at 40% (LO) VO2max for 70 minutes which expends ~400 kcal. This will be conducted prior to and following a 12 week exercise training intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288632 0
To understand whether genetic variants of the FTO gene influence the skeletal muscle’s ability to utilise carbohydrates, proteins and fats at a genetic and tissue level in response to a 12 week high intensity intermittent exercise training intervention.
Timepoint [1] 288632 0
Timepoints to be assessed will be the same for all 4 testing sessions (2 exercise testing sessions conducted before the intervention, and 2 exercise testing sessions after the intervention). The timepoints are at baseline/prior to exercise testing (DNA, serum & muscle), every 10 minutes during exercise (serum), immediately following exercise (serum), 15 minutes following exercise (serum & muscle), and 3 hours following exercise (serum & muscle).
Secondary outcome [1] 300664 0
Nil
Timepoint [1] 300664 0
Nil

Eligibility
Key inclusion criteria
Participants will be considered relatively healthy males with the FTO rs9939609 risk allele (A) or two FTO rs9939609 wild type alleles (TT). Participants will be included if they have adequate glucose handling (no diagnosed diabetes, fasting blood glucose must be less than 7.0 mmol/L), not performing any regular fitness training (i.e. greater than 30 minutes, 3 times per week) for the past 6 months, not taking contraindicated prescription medication (i.e. thyroid, hyperlipidmeic, hypoglycemic, or antihypertensive), do have physician approval (if BMI over 25kg.m-2), and not current involvement in other research studies.
Minimum age
20 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participating within the project for the following reasons: diagnosed diabetes (fasting blood glucose greater than 7.0 mmol/L or HbA1ctest greater than 6.5%), performing any regular fitness training (i.e. greater than 30 minutes, 3 times per week) for the past 6 months, taking contraindicated prescription medication (i.e. thyroid, hyperlipidmeic, hypoglycemic, or antihypertensive), no physician approval (if BMI over 25kg.m-2), and current involvement in other research studies.

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)
The order of the exercise testing (LO vs. HI) will be decided by coin toss by an individual independent to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS for Windows Version 18 software (SPSS Inc., Chicago, IL). An independent samples t-test will be calculated on all dependent variables to determine if significant differences exist at baseline between the two groups (healthy obese versus healthy lean controls). MANOVAs (grouped for variables of skeletal muscle protein, and skeletal muscle mRNA) will be used to analyse the pre- and post-exercise data to account for any dependent variables that may be related to one another. In addition, the use of a MANOVA analysis also prevents the chance of committing a Type I error that could result from the use of repeated univariate ANOVA procedures. For all dependent variables, repeated measures multivariate analysis of variance (MANOVA) will be utilized. Separate t-tests on each dependent variable will be conducted as follow-up tests to the MANOVA. To control for alpha inflation of the ANOVA, the Bonferroni test will be utilized. Data will be considered significantly different when the probability of error is 0.05 or less.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286560 0
University
Name [1] 286560 0
Victoria University
Country [1] 286560 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
McKechnie Street, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 285344 0
None
Name [1] 285344 0
Address [1] 285344 0
Country [1] 285344 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288628 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 288628 0
Ethics committee country [1] 288628 0
Australia
Date submitted for ethics approval [1] 288628 0
30/01/2013
Approval date [1] 288628 0
Ethics approval number [1] 288628 0

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

Contacts
Principal investigator
Name 37058 0
Dr Christos Stathis
Address 37058 0
Victoria University (Footscray Park Campus), Ballarat Rd, Footscray VIC 3011
Country 37058 0
Australia
Phone 37058 0
+61 03 9919 4293
Fax 37058 0
Email 37058 0
christos.stathis@vu.edu.au
Contact person for public queries
Name 37059 0
Jessica Danaher
Address 37059 0
Victoria University (St Albans Campus), McKechnie Street, St Albans VIC 3021
Country 37059 0
Australia
Phone 37059 0
+61 421 479 868
Fax 37059 0
Email 37059 0
jessica.danaher@live.vu.edu.au
Contact person for scientific queries
Name 37060 0
Jessica Danaher
Address 37060 0
Victoria University (St Albans Campus), McKechnie Street, St Albans VIC 3021
Country 37060 0
Australia
Phone 37060 0
+61 421 479 868
Fax 37060 0
Email 37060 0
jessica.danaher@live.vu.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.