Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000875808
Ethics application status
Not yet submitted
Date submitted
16/08/2012
Date registered
17/08/2012
Date last updated
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise training generate normal response in terms of aerobic capacity, mitochondrial function and insulin sensitivity in adult men who were born with low birth weight?
Scientific title
Does exercise training generate normal response in terms of aerobic capacity, mitochondrial function and insulin sensitivity in adult men who were born with low birth weight?
Secondary ID [1] 281044 0
NIL
Universal Trial Number (UTN)
U1111-1133-5631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes in those born with low birth weight 287179 0
Skeletal Muscle's response to exercise in those born with low birth weight 287180 0
Condition category
Condition code
Metabolic and Endocrine 287510 287510 0 0
Diabetes
Musculoskeletal 287511 287511 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Young (18-40 yrs) healthy male subjects (n=12/group) and those born small (Birth weight=1500-2500g) will be recruited and the peak pulmonary oxygen uptake (VO2 peak), a well-accepted measure of cardiorespiratory fitness, will be assessed. The body mass composition will also be assessed. Seven days later, they will report to the laboratory after an overnight fast and provide a muscle biopsy sample for biochemical and molecular analysis. Insulin sensitivity will then be measured by infusing glucose into the arm via a catheter (a euglycemic, hyperinsulinemic clamp). At the end of the clamp, a second muscle biopsy sample will be obtained for assessment of insulin signalling activation. The subjects will then undergo exercise training for 4 weeks (1 hour/day, 5 days a week) in our exercise lab. Subjects will then complete 4 weeks of exercise training that involves 60 min of exercise on a cycle ergometer per day for repeated blocks of 5 consecutive days, separated by a two days of rest. During the training the subjects will be performing cycling exercise for 1 hour for 4 days at 65% of their VO2 max. The subjects will be provided with an exercise bike to take home and they will perform the above mentioned exercise for 4 days at their home. The subjects will also be provided with a heart monitor to record their heart rate during exercise and monitor their activity levels.On the 5th day subjects will report to the laboratory, submit their heart monitors to the researchers and perform an interval training for 1 hour. At the end of the training the subjects will provide a post training VO2 peak test, leg muscle biopsies and another glucose infusion clamp will be performed to assess their response to training.
Intervention code [1] 285502 0
Lifestyle
Intervention code [2] 285512 0
Diagnosis / Prognosis
Comparator / control treatment
Exercise in adult males born with normal birth weight
Control group
Active

Outcomes
Primary outcome [1] 287757 0
Blood glucose levels (measured during an insulin clamp)
Timepoint [1] 287757 0
After 4 weeks of exercise training
Primary outcome [2] 287758 0
Blood insulin levels (measured during an insulin clamp)
Timepoint [2] 287758 0
After 4 weeks of exercise training
Secondary outcome [1] 298784 0
Skeletal Muscle Mitochondrial Biogenesis and function (measured from the analysis of leg muscle biopsy conducted before and after the insulin clamp)
Timepoint [1] 298784 0
After 4 weeks of exercise training

Eligibility
Key inclusion criteria
Born at term with either low birth weight (1400-2500g) or with normal birth weight
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants found to have a condition such as a heart disease, high blood pressure, participants on medicines such as warfarin, bleeding disorders and physical injury that could be compromised by exercise will be excluded in the pre-screening phase with the medical questionnaire.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects will be recruited via advertisements and posters and asked to fill a medical questionnaire. The selected subjects will be divided into two sub groups based on their birth weight; normal birth weight (2500-3200g) or low birth weight(1400-2500g)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Both low birth weight and normal birth weight group will receive same amount of exercise training
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5595 0
3011

Funding & Sponsors
Funding source category [1] 285827 0
Other Collaborative groups
Name [1] 285827 0
Collaborative Research Network (CRN)
Country [1] 285827 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Collaborative Research Network (CRN)
Address
Victoria University
PO Box 14438
Melbourne
Victoria 8001
Country
Australia
Secondary sponsor category [1] 284650 0
University
Name [1] 284650 0
Victoria University
Address [1] 284650 0
PO Box 14438
Melbourne
Victoria 8001
Country [1] 284650 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287845 0
VU HREC
Ethics committee address [1] 287845 0
Ethics committee country [1] 287845 0
Australia
Date submitted for ethics approval [1] 287845 0
14/06/2012
Approval date [1] 287845 0
Ethics approval number [1] 287845 0
HRETH 12/167

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

Contacts
Principal investigator
Name 34586 0
Address 34586 0
Country 34586 0
Phone 34586 0
Fax 34586 0
Email 34586 0
Contact person for public queries
Name 17833 0
Dr Gunveen Kaur
Address 17833 0
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University
PO Box 14428
Melbourne
VIC 8001
Country 17833 0
Australia
Phone 17833 0
+61 3 99194141
Fax 17833 0
Email 17833 0
[email protected]
Contact person for scientific queries
Name 8761 0
Dr Gunveen Kaur
Address 8761 0
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University
PO Box 14428
Melbourne
VIC 8001
Country 8761 0
Australia
Phone 8761 0
+61 3 99194141
Fax 8761 0
Email 8761 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.