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Trial registered on ANZCTR


Registration number
ACTRN12613001086752
Ethics application status
Approved
Date submitted
24/09/2013
Date registered
27/09/2013
Date last updated
27/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of exercise intensity on immune function and glucose regulation
Scientific title
Does high-intensity exercise have a different effect on immune function and glucose regulation when compared to moderate-intensity exercise in overweight sedentary males?
Secondary ID [1] 283273 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of type 2 diabetes/prediabetes 290147 0
Overweight/obesity 290191 0
Condition category
Condition code
Inflammatory and Immune System 290537 290537 0 0
Normal development and function of the immune system
Metabolic and Endocrine 290538 290538 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
A minimum wash-out period of three days will take place between trials.
Intervention code [1] 287998 0
Prevention
Comparator / control treatment
Moderate-intensity exercise @ 60% VO2max over a period of 30-minutes on a stationary cycle ergometer.
Control group
Active

Outcomes
Primary outcome [1] 290566 0
Glucose control via an oral glucose tolerance test and continuous glucose monitor
Timepoint [1] 290566 0
Day before exercise, day of exercise and the day following exercise
Secondary outcome [1] 304805 0
Inflammatory markers; pro- and anti-inflammatory markers such as IL-6, CRP and IL-10.
Timepoint [1] 304805 0
Blood samples will be collected immediately before exercise, immediately after exercise, 1h post-exercise and 24h post-exercise.

Eligibility
Key inclusion criteria
BMI > 25
Sedentary
Minimum age
18 Years
Maximum age
44 Years
Gender
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
Prevention
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
Crossover
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288013 0
Charities/Societies/Foundations
Name [1] 288013 0
McCusker Grant
Address [1] 288013 0
McCusker Charitable Foundation
PO Box Z5110
Perth Western Australia 6831
Country [1] 288013 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch 6150, Western Australia
Country
Australia
Secondary sponsor category [1] 286734 0
None
Name [1] 286734 0
Address [1] 286734 0
Country [1] 286734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289941 0
Murdoch University Ethics Committee
Ethics committee address [1] 289941 0
Murdoch University,
90 South Street,
Murdoch 6150,
Perth, Western Australia
Ethics committee country [1] 289941 0
Australia
Date submitted for ethics approval [1] 289941 0
21/06/2013
Approval date [1] 289941 0
05/08/2013
Ethics approval number [1] 289941 0
2013/121

Summary
Brief summary
Diabetes Mellitus is a global health concern and a national health priority area in Australia. In particular, type 2 diabetes mellitus (T2DM) is emerging as one of the greatest health threats in Australia, with approximately 90% of all individuals living with diabetes mellitus having T2DM. Being overweight or obese greatly increases the risk of progressing to T2DM (increasing the risk by four-fold). The link between obesity and progression to T2DM is attributed to changes in the immune system, specifically the inflammatory changes seen in individuals who are overweight or obese. Being inactive has also been shown to increase the risk of developing T2DM by two-fold. Although we know that the intensity of exercise can change the level of improvement seen in insulin sensitivity (higher intensity having greater effect), there is limited research investigating the role of high-intensity intermittent exercise (HIT) on insulin sensitivity. HIT uses alternating bouts of high-intensity and low-intensity exercise over the duration of the exercise bout and has recently demonstrated significant beneficial effects on health measures including body mass index (BMI).


Therefore, the purpose of this study is to determine how insulin sensitivity and the immune system can be affected by exercise intensity. We hypothesise that the high-intensity intermittent exercise will be more effective in regulating glucose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43162 0
Mr Aaron Raman
Address 43162 0
Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 43162 0
Australia
Phone 43162 0
+61893601389
Fax 43162 0
Email 43162 0
A.Raman@murdoch.edu.au
Contact person for public queries
Name 43163 0
Mr Aaron Raman
Address 43163 0
Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 43163 0
Australia
Phone 43163 0
+61893601389
Fax 43163 0
Email 43163 0
A.Raman@murdoch.edu.au
Contact person for scientific queries
Name 43164 0
Mr Aaron Raman
Address 43164 0
Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150
Country 43164 0
Australia
Phone 43164 0
+61893601389
Fax 43164 0
Email 43164 0
A.Raman@murdoch.edu.au

No data has been provided for results reporting
Summary results
Not applicable