Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000613505
Ethics application status
Approved
Date submitted
20/02/2015
Date registered
12/06/2015
Date last updated
12/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
12 weeks of exercise training and its effect on immune function and glucose regulation.
Scientific title
In overweight/obese males, does exercise intensity (high-intensity interval training vs continuous moderate-intensity) have an influence on immune function and glucose regulation?
Secondary ID [1] 285308 0
none.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of type 2 diabetes/prediabetes
 293013 0
Overweight/obesity 294411 0
Condition category
Condition code
Metabolic and Endocrine 293288 293288 0 0
Diabetes
Inflammatory and Immune System 293294 293294 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise training consisting of either:
High intensity exercise (HIT) or continuous moderate-intensity (CME)

HIT - 6 bouts of high-intensity intermittent exercise @ 100% VO2max, on a stationary cycle ergometer with a work-to-rest ratio of 1:4 over a period of 30-minutes. Active recovery consists of cycling @ 50% VO2max and performance will be monitored on the software associated with the cycle ergometer.

CME - Moderate-intensity exercise @ 60% VO2max over a period of 30-minutes on a stationary cycle ergometer.

3 sessions per week
12 weeks
Group session
The researcher will administer the intervention. Dr. Timothy Fairchild is an ESSA Accredited Exercise Physiologist and Aaron Raman is a PhD student in exercise science.

Exercise adherence will be noted with an exercise log.
Intervention code [1] 292004 0
Lifestyle
Comparator / control treatment
The control group will consist of a no-exercise group.
Only lifestyle advice will be provided. Participants will also be offered a training program after first 12-weeks of control.
Control group
Active

Outcomes
Primary outcome [1] 293127 0
Glucose control via an oral glucose tolerance test and continuous glucose monitor
Insulin sensitivity via serum insulin
Timepoint [1] 293127 0
Baseline, halfway (week 6) and post-training (week 12).
Secondary outcome [1] 310415 0
Inflammatory markers; pro- and anti-inflammatory markers such as IL-6, CRP and IL-10.
Timepoint [1] 310415 0
Baseline, halfway (week 6) and post-training (week 12).
Blood samples will be collected in a fasted state.

Eligibility
Key inclusion criteria
BMI > 25
Sedentary
Minimum age
18 Years
Maximum age
44 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previously diagnosed with Type 2 diabetes
Have an inflammatory disease
Taking medication that may affect blood pressure, glucose control and/or cholesterol.

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)
Randomisation by computer, and then placed into sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289929 0
Charities/Societies/Foundations
Name [1] 289929 0
McCusker Grant
Country [1] 289929 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch 6150, Western Australia
Country
Australia
Secondary sponsor category [1] 288621 0
None
Name [1] 288621 0
Address [1] 288621 0
Country [1] 288621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291646 0
Murdoch University Ethics Committee
Ethics committee address [1] 291646 0
Murdoch University,
90 South Street,
Murdoch 6150,
Perth, Western Australia
Ethics committee country [1] 291646 0
Australia
Date submitted for ethics approval [1] 291646 0
01/08/2014
Approval date [1] 291646 0
08/09/2014
Ethics approval number [1] 291646 0
2014/170

Summary
Brief summary
40 participants will be recruited to complete a 12-week exercise training intervention which consists of either high-intensity intermittent exercise or continuous moderate-intensity exercise on a cycle ergometer. This study aims to determine the effect of exercise training on the changes in insulin sensitivity and the immune system as a result of a training adaptation over the 12-week period. This will be a parallel randomised group design which will include male participants between the age of 18-44 years old who are overweight (BMI greater than or equal to 25 kg/m2) but otherwise healthy (no previous history of type 2 diabetes or other immune-related diseases).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51318 0
Mr Aaron Raman
Address 51318 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 51318 0
Australia
Phone 51318 0
+61893601389
Fax 51318 0
Email 51318 0
[email protected]
Contact person for public queries
Name 51319 0
Mr Aaron Raman
Address 51319 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 51319 0
Australia
Phone 51319 0
+61893601389
Fax 51319 0
Email 51319 0
[email protected]
Contact person for scientific queries
Name 51320 0
Mr Aaron Raman
Address 51320 0
REF3.001, Refectory building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 51320 0
Australia
Phone 51320 0
+61893601389
Fax 51320 0
Email 51320 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.