Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001220651
Ethics application status
Approved
Date submitted
6/11/2014
Date registered
19/11/2014
Date last updated
23/08/2019
Date data sharing statement initially provided
23/08/2019
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
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
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
Diabetes
Cardiovascular 293731 293731 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Lifestyle
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
Active

Outcomes
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).

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Health contraindications to exercise.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Intervention randomisation was performed through a computer generated list (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
3/08/2015
Date of last participant enrolment
Anticipated
Actual
20/01/2019
Date of last data collection
Anticipated
Actual
3/05/2019
Sample size
Target
75
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW

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
Country [1] 303646 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The Charles Perkins Centre,
John Hopkins Drive,
Camperdown, NSW
2050
Country
Australia
Secondary sponsor category [1] 288905 0
University
Name [1] 288905 0
Australian Catholic University
Address [1] 288905 0
25A Barker Road,
Strathfield, NSW
2135
Country [1] 288905 0
Australia
Secondary sponsor category [2] 288906 0
University
Name [2] 288906 0
University of Newcastle
Address [2] 288906 0
10 Chittaway Road,
Ourimbah, NSW
2258
Country [2] 288906 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 291907 0
14/11/2014
Approval date [1] 291907 0
25/03/2015
Ethics approval number [1] 291907 0

Summary
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
/AnzctrAttachments/367370-Ethics Approval Letter USyd 25032015.pdf

Contacts
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
Australia
Phone 52538 0
+612 9351 9137
Fax 52538 0
Email 52538 0
nathan.johnson@sydney.edu.au
Contact person for public queries
Name 52539 0
Rachelle Sultana
Address 52539 0
The Charles Perkins Centre,
John Hopkins Drive,
Camperdown, NSW
2050
Country 52539 0
Australia
Phone 52539 0
+61 450660193
Fax 52539 0
Email 52539 0
rachelle.sultana@sydney.edu.au
Contact person for scientific queries
Name 52540 0
Nathan Johnson
Address 52540 0
The University of Sydney,
Discipline of Exercise and Sport Science,
PO Box170,
Lidcombe, NSW,
2141 C42
Country 52540 0
Australia
Phone 52540 0
+612 9351 9137
Fax 52540 0
Email 52540 0
nathan.johnson@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


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
SourceTitleYear of PublicationDOI
EmbaseThe effect of a novel low-volume aerobic exercise intervention on liver fat in type 2 diabetes: A randomized controlled trial.2020https://dx.doi.org/10.2337/dc19-2523
EmbaseDegree of adiposity and obesity severity is associated with cutaneous microvascular dysfunction in type 2 diabetes.2021https://dx.doi.org/10.1016/j.mvr.2021.104149
EmbaseThe Efficacy of Exercise Training for Cutaneous Microvascular Reactivity in the Foot in People with Diabetes and Obesity: Secondary Analyses from a Randomized Controlled Trial.2022https://dx.doi.org/10.3390/jcm11175018
N.B. These documents automatically identified may not have been verified by the study sponsor.