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
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
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
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
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

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

Documents added automatically
No additional documents have been identified.