Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000906055
Ethics application status
Approved
Date submitted
22/10/2010
Date registered
25/10/2010
Date last updated
25/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Glucose response to single sessions of resistance and aerobic exercise in people with type 2 diabetes
Scientific title
Glycaemic variation in response to a single session of exercise in people with type 2 diabetes treated with insulin
Secondary ID [1] 252940 0
Nil
Universal Trial Number (UTN)
Trial acronym
The ExerGRID study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 258471 0
Condition category
Condition code
Metabolic and Endocrine 258637 258637 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The single full body resistance exercise session using machines and free weights administered individually by an accredited exercise physiologist. It will take approximately 40 minutes to complete 3 sets of 10 repetitions for each of the 6 exercises at 70% of 1RM. The 6 exercises will consist of three upper (supine bench press, lateral pull-down, seated upright row) and three lower (incline seated leg press, leg curl, leg extension) body exercises.

There will then be a seven day washout period before undertaking the aerobic exercise session.
Intervention code [1] 257465 0
Behaviour
Intervention code [2] 257478 0
Treatment: Other
Comparator / control treatment
One 30 minute session of aerobic exercise completed under the supervision of an accredited exercise physiologist will be completed on a cycle ergometer at 60% of VO2 max.

There will then be a seven day washout period before undertaking the resistance exercise session.
Control group
Active

Outcomes
Primary outcome [1] 259480 0
Glucose variation using a continuous glucose monitor
Timepoint [1] 259480 0
continuous for 3 days post intervention
Secondary outcome [1] 266062 0
Insulin sensitivity using HOMA calculations from fasting glucose and insulin levels. Adiponectin will also be measured as a surrogate marker.
Timepoint [1] 266062 0
immediately post exercise & 72 hours post exercise
Secondary outcome [2] 266063 0
Aspirin resistance will be measured by separating some of the collected blood into two separate tubes, one containing a vehicle agent and one conataining aspirin before being analysed for platelet aggregation.
Timepoint [2] 266063 0
immediately post exercise & 72 hours post exercise

Eligibility
Key inclusion criteria
Males and females aged 50-70 years with established type 2 diabetes (>6 months)
Treated with exogenous insulin
Stable weight over the past 3 months
Stable glycaemic control of greater than or equal to 8 weeks
HbA1c between 7.0% and 10% at screening
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of beta-blockers and/or oral anti-hyperglycaemic medication for less than 6-months
Impaired liver function
Renal failure
Severe retinopathy
Recent myocardial infarction
Unstable angina
Chronic heart failure
Recent exacerbation of respiratory disease
Exceeding the national recommendations for exercise, which are: at least 30 minutes of moderate-intensity aerobic activity on 5 days of the week for at least 3 months (150 minutes plus per week) and/or at least 30 minutes of vigorous-intensity aerobic activity on 3 days of the week for at least 3 months (90 minutes plus per week)
Any strength training for 2 or more sessions per week in last 3 months

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)
This is a randomised crossover trial. Concealed randomisation stratified by gender will allocate participants to complete the resistance exercise or aerobic exercise protocol first. An independent person, not involved in the research protocol will allocate using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Resistance Exercise and Aerobic Exercise will be placed in a computer based random sequence generator. The sequence will be generated based on sex and in blocks.
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
8/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257917 0
Other Collaborative groups
Name [1] 257917 0
Centre for Metabolic Fitness
Country [1] 257917 0
Australia
Primary sponsor type
Individual
Name
Dr Amanda Benson
Address
RMIT University
PO Box 71
Bundoora, VIC, 3083
Country
Australia
Secondary sponsor category [1] 257106 0
None
Name [1] 257106 0
N/A
Address [1] 257106 0
NA
Country [1] 257106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259930 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 259930 0
Ethics committee country [1] 259930 0
Australia
Date submitted for ethics approval [1] 259930 0
Approval date [1] 259930 0
Ethics approval number [1] 259930 0
Ethics committee name [2] 259931 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 259931 0
Ethics committee country [2] 259931 0
Australia
Date submitted for ethics approval [2] 259931 0
Approval date [2] 259931 0
Ethics approval number [2] 259931 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31822 0
Address 31822 0
Country 31822 0
Phone 31822 0
Fax 31822 0
Email 31822 0
Contact person for public queries
Name 15069 0
Brett Gordon
Address 15069 0
Exercise Sciences, RMIT University
PO Box 71
Bundoora, VIC, 3083
Country 15069 0
Australia
Phone 15069 0
+61 3 99257037
Fax 15069 0
Email 15069 0
[email protected]
Contact person for scientific queries
Name 5997 0
Dr Amanda Benson
Address 5997 0
Exercise Sciences, RMIT University
PO Box 71
Bundoora, VIC, 3083
Country 5997 0
Australia
Phone 5997 0
+61 3 99257677
Fax 5997 0
Email 5997 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
SourceTitleYear of PublicationDOI
EmbaseDoes a single bout of resistance or aerobic exercise after insulin dose reduction modulate glycaemic control in type 2 diabetes? A randomised cross-over trial.2016https://dx.doi.org/10.1016/j.jsams.2016.01.004
N.B. These documents automatically identified may not have been verified by the study sponsor.