ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Overweight/obesity

Condition category

Condition code

Inflammatory and Immune System

Normal development and function of the immune system

Metabolic and Endocrine

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]

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]

Glucose control via an oral glucose tolerance test and continuous glucose monitor

Timepoint [1]

Day before exercise, day of exercise and the day following exercise

Secondary outcome [1]

Inflammatory markers; pro- and anti-inflammatory markers such as IL-6, CRP and IL-10.

Timepoint [1]

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

Sex

Males

Can healthy volunteers participate?

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

1/10/2013

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)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

McCusker Grant

Address [1]

McCusker Charitable Foundation
PO Box Z5110
Perth Western Australia 6831

Country [1]

Australia

Primary sponsor type

University

Name

Murdoch University

Address

90 South Street, Murdoch 6150, Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Ethics Committee

Ethics committee address [1]

Murdoch University,
90 South Street,
Murdoch 6150,
Perth, Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/06/2013

Approval date [1]

05/08/2013

Ethics approval number [1]

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

Mr Aaron Raman

Address

Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150

Country

Australia

Phone

+61893601389

Fax

A.Raman@murdoch.edu.au

Contact person for public queries

Name

Aaron Raman

Address

Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150

Country

Australia

Phone

+61893601389

Fax

A.Raman@murdoch.edu.au

Contact person for scientific queries

Name

Aaron Raman

Address

Room 4.005 Economics, Commerce and Law Building, Murdoch University, 90 South Street, Murdoch WA 6150

Country

Australia

Phone

+61893601389

Fax

A.Raman@murdoch.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Exercise-induced responses in matrix metalloproteinases and osteopontin are not moderated by exercise format in males with overweight or obesity.	2023	https://dx.doi.org/10.1007/s00421-023-05133-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically