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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel Exercise Strategies for the Management of Type 2 Diabetes
Scientific title
In individuals with type 2 diabetes, does high intensity interval exercise training, when compared to continuous moderate aerobic exercise and a control, produce physiological changes in glucose, cardiovascular and fat outcome measures?
Secondary ID [1] 285604 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 293449 0
Cardiovascular disease 293450 0
Condition category
Condition code
Metabolic and Endocrine 293730 293730 0 0
Cardiovascular 293731 293731 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Intervention groups: Participants will be randomised into the following groups: a) Supervised high intensity interval training as a single bout of aerobic exercise (4 mins; 90% VO2max) ; b) Supervised traditional prolonged moderate intensity aerobic exercise (45 mins; 60% VO2max); c) control group who will receive standard physical activity and dietary advice. All exercise is to be performed on a stationary cycle ergometer.

Exercise sessions are to be completed by the participants 3 times per week, for a duration of 12 weeks.

Participants who are randomised into the high intensity group will progressively increase the duration from 1 minute at 90%VO2max to 4 minutes. The moderate intensity group will incrementally progress in intensity in accordance to training adaptations.

All exercising participants will be supervised by an Accredited Exercise Physiologist and records of heart rate and rating of perceived exertion (RPE) will be collected during each exercise session. Blood glucose measures will be taken prior to exercise and if symptoms arise of hypo/hyperglycaemia.

Intervention code [1] 290556 0
Intervention code [2] 290581 0
Treatment: Other
Comparator / control treatment
Participants allocated to the "control" condition" will receive an initial individual counseling session (approximately 1 hour) with one of the study investigators involving advise on physical activity as per current Australian recommendations. This includes doing activity on most days of the week aiming for a minimum of 150 min per week of moderate intensity aerobic activities and counseling on appropriate activities. Participants will also receive advice on healthy eating (as per current NHMRC guidelines) focusing on low saturated fat, low alcohol and high fibre intake with counseling on portion sizes. Participants will also receive further one-on-one follow up sessions each 3 weeks (approximately 45 min each) for the entire intervention period (12 weeks).
Control group

Primary outcome [1] 293530 0
Augmentation index. This will be completed using Applanation Tonometry.
Timepoint [1] 293530 0
Baseline, post intervention (3 months), and follow-up (6 months)
Primary outcome [2] 293624 0
Pulse wave velocity. This will be completed using Applanation Tonometry.
Timepoint [2] 293624 0
Baseline, post intervention (3 months), follow-up (6 months)
Secondary outcome [1] 311268 0
Abdominal fat content (subcutaneous) will be collected using magnetic resonance imaging (MRI).
Timepoint [1] 311268 0
Baseline, post-intervention (3 months), and follow up (6 months)
Secondary outcome [2] 311269 0
Skin blood flow will be collected using Doppler ultrasound.
Timepoint [2] 311269 0
Baseline, post-intervention (3 months), and follow up (6 months)
Secondary outcome [3] 311270 0
Cardiorespiratory fitness assessed via graded exercise test on a stationary cycle ergometer to maximal aerobic capacity. This will be calculated using a breath by breath gas exchange analyser. The test will start at 35 Watts and 65 Watts for men and women respectively and increase by 25W every 2.5 minutes until volitional fatigue or other test termination criteria reached. Heart rate and rating of perceived exertion (RPE) will be collected every minute duration the test.
Timepoint [3] 311270 0
Baseline, post-intervention (3 months), follow up (6 months)
Secondary outcome [4] 311352 0
Abdominal fat content (visceral adipose tissue) will be collected using magnetic resonance imaging (MRI).
Timepoint [4] 311352 0
Baseline, post-intervention (3 months)
Secondary outcome [5] 311353 0
Liver fat will be collected using magnetic resonance imaging (MRI).
Timepoint [5] 311353 0
Baseline, post-intervention (3-months)
Secondary outcome [6] 339368 0
Pancreatic fat will be collected using magnetic resonance imaging (MRI).
Timepoint [6] 339368 0
Baseline, post-intervention (3-months).

Key inclusion criteria
Participants must have type 2 diabetes, body mass index 30-45kg/metres squared, be free from contraindications to exercise training, and not meet the current guidelines for recommended levels of physical activity (3 days a week or > 150 mins per week)
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Health contraindications to exercise.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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)
Intervention randomisation was performed through a computer generated list (
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 303646 0
Government body
Name [1] 303646 0
Collaborative Research Network for Advancing Exercise & Sports Science (CRN-AESS)/Research Capacity Building Seeding Grant Scheme
Address [1] 303646 0
Bond University: 14 University Dr, Robina QLD 4226, Australia.
Country [1] 303646 0
Primary sponsor type
University of Sydney
The Charles Perkins Centre,
John Hopkins Drive,
Camperdown, NSW
Secondary sponsor category [1] 288905 0
Name [1] 288905 0
Australian Catholic University
Address [1] 288905 0
25A Barker Road,
Strathfield, NSW
Country [1] 288905 0
Secondary sponsor category [2] 288906 0
Name [2] 288906 0
University of Newcastle
Address [2] 288906 0
10 Chittaway Road,
Ourimbah, NSW
Country [2] 288906 0

Ethics approval
Ethics application status
Ethics committee name [1] 291907 0
University of Sydney
Ethics committee address [1] 291907 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 291907 0
Date submitted for ethics approval [1] 291907 0
Approval date [1] 291907 0
Ethics approval number [1] 291907 0

Brief summary
Aims and hypotheses: To examine the efficacy of novel versus traditional exercise therapies on metabolic and cardiovascular outcomes in adults with type 2 diabetes. We hypothesize that all exercise interventions will improve abdominal, liver and pancreas fat levels, insulin sensitivity, fitness and cardiovascular health compared with control.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 619 619 0 0

Principal investigator
Name 52538 0
Dr Nathan Johnson
Address 52538 0
The University of Sydney,
Discipline of Exercise and Sport Science,
PO Box170,
Lidcombe, NSW,
2141 C42
Country 52538 0
Phone 52538 0
+612 9351 9137
Fax 52538 0
Email 52538 0
Contact person for public queries
Name 52539 0
Ms Rachelle Sultana
Address 52539 0
The Charles Perkins Centre,
John Hopkins Drive,
Camperdown, NSW
Country 52539 0
Phone 52539 0
+61 450660193
Fax 52539 0
Email 52539 0
Contact person for scientific queries
Name 52540 0
Dr Nathan Johnson
Address 52540 0
The University of Sydney,
Discipline of Exercise and Sport Science,
PO Box170,
Lidcombe, NSW,
2141 C42
Country 52540 0
Phone 52540 0
+612 9351 9137
Fax 52540 0
Email 52540 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
No - IPD will not be available
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary