Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001509459
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
1/11/2016
Date last updated
3/11/2016
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
none
Universal Trial Number (UTN)
U1111-1186-7380
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
Diabetes
Inflammatory and Immune System 299894 299894 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-diabetic, healthy and active individuals.
BMI < 27

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)
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
Parallel
Other design features
Longitudinal
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2016
Actual
30/09/2016
Date of last participant enrolment
Anticipated
12/05/2017
Actual
Date of last data collection
Anticipated
12/05/2017
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294362 0
University
Name [1] 294362 0
Murdoch University
Country [1] 294362 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch 6150, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 293203 0
None
Name [1] 293203 0
Address [1] 293203 0
Country [1] 293203 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 295786 0
06/10/2015
Approval date [1] 295786 0
21/12/2015
Ethics approval number [1] 295786 0
2015/220

Summary
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

Contacts
Principal investigator
Name 68454 0
Mr Aaron Raman
Address 68454 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 68454 0
Australia
Phone 68454 0
+61434989123
Fax 68454 0
Email 68454 0
[email protected]
Contact person for public queries
Name 68455 0
Mr Aaron Raman
Address 68455 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 68455 0
Australia
Phone 68455 0
+61434989123
Fax 68455 0
Email 68455 0
[email protected]
Contact person for scientific queries
Name 68456 0
Mr Aaron Raman
Address 68456 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 68456 0
Australia
Phone 68456 0
+61434989123
Fax 68456 0
Email 68456 0
[email protected]

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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