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
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
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
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
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]

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.