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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short-term exercise training and its effect on glucose tolerance and immune function
Scientific title
Two weeks of cycling or treamdill exercise and its effect on glucose tolerance and T regulatory cells in individuals with type 2 diabetes
Secondary ID [1] 289992 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 299999 0
Condition category
Condition code
Metabolic and Endocrine 299893 299893 0 0
Inflammatory and Immune System 299894 299894 0 0
Other inflammatory or immune system disorders

Study type
Description of intervention(s) / exposure
Participants will be randomised into an exercise group of either treadmill or cycle exercise.
Exercise will last for 45 minutes (moderate intensity at 65% of VO2peak) and will last for 10 sessions over a two-week period at the Murdoch University exercise physiology laboratory.

An oral glucose tolerance test will be completed pre and post-training with blood samples taken every 30 minutes. Blood samples will also be used to measure immune related cells such as regulatory T cells.

Familiarisation will preceed training with a VO2peak test, body composition analysis and anthropometrics measured.

Exercise will be supervised by the PhD student who is running the project.
Intervention code [1] 295693 0
Treatment: Other
Comparator / control treatment
Treadmill exercise group
Control group

Primary outcome [1] 299376 0
Glucose tolerance via oral glucose tolerance test (75g glucose).
Participants will ingest a 75g-carbohydrate containing drink in a fasted state.
Timepoint [1] 299376 0
Pre and post two week training period.
Blood samples will be collected pre-ingestion and every 30 minutes for two hours.
Secondary outcome [1] 326979 0
Regulatory T cells will be assessed via flow cytometry from whole blood samples collected prior to the ingestion of the oral glucose tolerance test.
Timepoint [1] 326979 0
Pre and post two week training

Key inclusion criteria
Diagnosed as type 2 diabetic,
BMI > 27
Sedentary or low level of physical activity (1 or 2 bouts per week)
Minimum age
18 Years
Maximum age
60 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Non-diabetic, healthy and active individuals.
BMI < 27

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Analysis of variance with repeated measures comparing within and between groups..
Based on Nieman et al. (Brain, Behaviour and Immunity, 2014 DOI: 10.1016). 20 participants will provide 80% power accounting for drop out to detect a difference in IL-6 marker with the a-error probability set at 0.05; f=0.875. This sample size was also increased as other markers will also be measured.

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] 294362 0
Name [1] 294362 0
Murdoch University
Address [1] 294362 0
90 South Street, Murdoch 6150, Perth, Western Australia
Country [1] 294362 0
Primary sponsor type
Murdoch University
90 South Street, Murdoch 6150, Perth, Western Australia
Secondary sponsor category [1] 293203 0
Name [1] 293203 0
Address [1] 293203 0
Country [1] 293203 0

Ethics approval
Ethics application status
Ethics committee name [1] 295786 0
Murdoch University Human Ethics Committee
Ethics committee address [1] 295786 0
90 South St, Murdoch 6150, Perth, Western Australia
Ethics committee country [1] 295786 0
Date submitted for ethics approval [1] 295786 0
Approval date [1] 295786 0
Ethics approval number [1] 295786 0

Brief summary
Current evidence suggests exercise plays an important role in the management of blood glucose levels for individuals with T2DM.The comparison on mode of exercise on glucose regulation is not well understood and limited. Previous research have investigated treadmill or cycling exercise on glucose tolerance separately, however the comparison between the two modes of exercise on glucose regulation is limited. We seek to determine which mode of exercise would be more effective in managing glucose tolerance since walking/running is freely accessible without having the need to sign up to a gym or to invest in a bicycle. It is now understood that type 2 diabetes is associated with a chronic state of inflammation. Recent evidence have shown that exercise is beneficial in improving inflammation along with reducing insulin resistance. We aim to identify whether the mode of exercise influences the level of inflammation and glucose tolerance following a two-week training period. Findings of this study may help inform future exercise prescription to improving health status in this population.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 68454 0
Mr Aaron Raman
Address 68454 0
Murdoch University,
90 South St
Murdoch 6150
Western Australia
Country 68454 0
Phone 68454 0
Fax 68454 0
Email 68454 0
Contact person for public queries
Name 68455 0
Mr Aaron Raman
Address 68455 0
Murdoch University,
90 South St
Murdoch 6150
Western Australia
Country 68455 0
Phone 68455 0
Fax 68455 0
Email 68455 0
Contact person for scientific queries
Name 68456 0
Mr Aaron Raman
Address 68456 0
Murdoch University,
90 South St
Murdoch 6150
Western Australia
Country 68456 0
Phone 68456 0
Fax 68456 0
Email 68456 0

No information has been provided regarding IPD availability
Summary results
No Results