Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000286347
Ethics application status
Approved
Date submitted
23/02/2017
Date registered
24/02/2017
Date last updated
24/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term exercise training and its effect on glucose tolerance and immune function.
Scientific title
Two weeks of moderate-intensity treadmill exercise and its effect on glucose tolerance and T regulatory cells in individuals with type 2 diabetes.
Secondary ID [1] 291245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 302175 0
Condition category
Condition code
Metabolic and Endocrine 301784 301784 0 0
Diabetes
Inflammatory and Immune System 301785 301785 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete moderate-intensity exercise on a treadmill.
Exercise will last for 45 minutes (moderate intensity at 65% of VO2peak) and will last for 12 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] 297251 0
Treatment: Other
Comparator / control treatment
Baseline measurements - pre-exercise training.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301185 0
Glucose tolerance via oral glucose tolerance test (75g glucose).
Participants will ingest a 75g-carbohydrate containing drink in a fasted state.
Timepoint [1] 301185 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] 331973 0
Regulatory T cells will be assessed via flow cytometry from whole blood samples.
Timepoint [1] 331973 0
Blood samples will be collected prior to and immediately following the first and last exercise session of the training period.

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
65 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
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
1/11/2017
Actual
Date of last data collection
Anticipated
1/03/2018
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295698 0
University
Name [1] 295698 0
Murdoch University
Country [1] 295698 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch 6150, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 294547 0
None
Name [1] 294547 0
Address [1] 294547 0
Country [1] 294547 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297004 0
Murdoch University Human Ethics Committee
Ethics committee address [1] 297004 0
90 South St, Murdoch 6150, Perth, Western Australia
Ethics committee country [1] 297004 0
Australia
Date submitted for ethics approval [1] 297004 0
06/10/2015
Approval date [1] 297004 0
21/12/2015
Ethics approval number [1] 297004 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 frequency of consecutive exercise session over a two-week period on glucose regulation is not well understood and limited. Previous research have investigated either combined exercise or a single mode of exercise on glucose tolerance, However the comparison of 12 consecutive session of exercise remains limited, especially in a clinical population of type 2 diabetes. We seek to determine how effective treadmill exercise is in managing glucose tolerance since walking/running is freely accessible without the need to sign up to a gym. 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 the influence of exercise on 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 72686 0
Mr Aaron Raman
Address 72686 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 72686 0
Australia
Phone 72686 0
+61434989123
Fax 72686 0
Email 72686 0
[email protected]
Contact person for public queries
Name 72687 0
Mr Aaron Raman
Address 72687 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 72687 0
Australia
Phone 72687 0
+61434989123
Fax 72687 0
Email 72687 0
[email protected]
Contact person for scientific queries
Name 72688 0
Mr Aaron Raman
Address 72688 0
Murdoch University,
90 South St
Murdoch 6150
Perth
Western Australia
Country 72688 0
Australia
Phone 72688 0
+61434989123
Fax 72688 0
Email 72688 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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