Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000289314
Ethics application status
Approved
Date submitted
2/06/2008
Date registered
10/06/2008
Date last updated
22/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The acute effects of resistance exercise on insulin sensitvity.
Scientific title
Insulin sensitivity in response to an acute bout of resistance exercise in type 2 diabetic and non-diabetic individuals
Secondary ID [1] 252937 0
Exercise and insulin sensitivity
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes and non-diabetic individuals 3220 0
Condition category
Condition code
Metabolic and Endocrine 3384 3384 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single session of resistance training using 5 exercises (bench press, leg press, shoulder press, calf raises, lat pull-down) completing 3 sets of 10 repetitions at 45%, 60% and 75% of one repetition maximum. This exercise session with cool down stretches takes approximately one hour to complete
Intervention code [1] 2960 0
Treatment: Other
Comparator / control treatment
Non diabetic individuals who recieve the same single session of resistance exercise and type 2 diabetic individuals who complete no exercise
Control group
Active

Outcomes
Primary outcome [1] 4279 0
Insulin Sensitivity (Oral glucose tolerance test area under insulin curve) and Homeostasis model assessments (HOMA) calculations measured from blood samples
Timepoint [1] 4279 0
24 hours
48 hours
72 hours
96 hours
Secondary outcome [1] 7211 0
Glucose tolerance (area under glucose curve) measured from blood samples
Timepoint [1] 7211 0
24 hours
48 hours
72 hours
96 hours
Secondary outcome [2] 7212 0
C-reactive protein measured from a fasting blood sample
Timepoint [2] 7212 0
24 hours
48 hours
72 hours
96 hours

Eligibility
Key inclusion criteria
Type 2 diabetes
Sedentary (less than 20 minutes of aerobic exercise twice a week)
Minimum age
40 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent coronary event
Uncontrolled hypertension
Significant orthopaedic disorder that would prevent them from completing resistance training
Chronic alcohol users
Any other medical condition that has resistance training as a contraindication
Taking insulin
Inability to understand English or follow instructions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
16/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3444 0
University
Name [1] 3444 0
RMIT University
Country [1] 3444 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Rd
Bundoora, Victoira, 3083
Country
Australia
Secondary sponsor category [1] 3094 0
None
Name [1] 3094 0
Address [1] 3094 0
Country [1] 3094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5471 0
RMIT University HREC
Ethics committee address [1] 5471 0
Ethics committee country [1] 5471 0
Australia
Date submitted for ethics approval [1] 5471 0
Approval date [1] 5471 0
Ethics approval number [1] 5471 0

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

Contacts
Principal investigator
Name 28637 0
Address 28637 0
Country 28637 0
Phone 28637 0
Fax 28637 0
Email 28637 0
Contact person for public queries
Name 11794 0
Brett Gordon
Address 11794 0
Exercise Sciences - RMIT University
PO Box 71
Bundoora, Victoria
Country 11794 0
Australia
Phone 11794 0
+61 3 99257037
Fax 11794 0
Email 11794 0
[email protected]
Contact person for scientific queries
Name 2722 0
Brett Gordon
Address 2722 0
Exercise Sciences - RMIT University
PO Box 71
Bundoora, Victoria
Country 2722 0
Australia
Phone 2722 0
+61 3 99257037
Fax 2722 0
Email 2722 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.