Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12612000178842
Ethics application status
Not yet submitted
Date submitted
6/02/2012
Date registered
9/02/2012
Date last updated
9/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and vascular function - The acute effect of a single bout of aerobic exercise on vascular function in metabolic syndrome and pre-diabetic males
Scientific title
The acute effect of a single bout of aerobic exercise on vascular function in metabolic syndrome and pre-diabetic males
Secondary ID [1] 279883 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular function 285784 0
Condition category
Condition code
Cardiovascular 285960 285960 0 0
Other cardiovascular diseases
Metabolic and Endocrine 285965 285965 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be required to attend three testing sessions over 4 days with at least 24 hours (1 day) of recovery day between Session 2 and 3. In Session 1 (day 1), subjects will undergo a glucose tolerance test (GTT). Based on the GTT results subjects then will be categorized into normal, impaired, or high glucose levels. In Session 2 (day 2), subjects will be required to perform maximal oxygen uptake (VO2max) test to determine the exercise load that will be used in Session 3. In Session 3 (day 4), subjects will perform a single bout of moderate intensity exercise on the bike for 30 min. All variables will be measured at pre and post acute exercise. During exercise subjects will be supervised and their heart rate will be monitored every 2 min by the tester/researcher.
Intervention code [1] 284203 0
Other interventions
Intervention code [2] 284209 0
Lifestyle
Intervention code [3] 284210 0
Prevention
Comparator / control treatment
All three groups will receive the same treatment. Any of these groups will not be deemed as a control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286455 0
Glucose levels as assessed by glucose tolerance test
Timepoint [1] 286455 0
In Session 1
Primary outcome [2] 286456 0
Vascular function as assessed by Hokanson Plethysmography
Timepoint [2] 286456 0
In Session 3, 48 hours after VO2max test
Secondary outcome [1] 295921 0
Physical fitness as assessed by VO2max test
Timepoint [1] 295921 0
In Session 2

Eligibility
Key inclusion criteria
Young individuals with body mass index (BMI) ranging between 25-35 kg/m2; non athletes (exercise no more than 3 times/week for 30 min each session; free of medication and diseases. Also, they will posses metabolic syndrome criteria (waist circumference greater than or equal to 94 cm and any two of the following: triglyceride level greater than or equal to 1.7 mmol/L; HDL cholesterol <1.03 mmol/L; systolic blood pressure greater than or equal to 130 mmHg or diastolic blood pressure greater than or equal to 85 mmHg; fasting plasma glucose greater than or equal to 5.6 mmol/L) and high glucose levels following a glucose tolerance test.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Trained individuals (athletes); diabetes; use of medications; hypertension

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)
Subjects that meet the inclusion criteria will be admitted to the study. All subjects will receive the same treatment and allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following a glucose tolerance test, subjects will be categorized into normal, impaired, or high glucose level group. Thus, the categorization is based on the level of subject's glucose. If subjecs' glucose level normal, then they will be allocated into a normal group. The same method of allocation will be used for the other 2 groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
There will be three groups of subject in the study and all the three groups will receive the same treatment.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284654 0
Self funded/Unfunded
Name [1] 284654 0
Country [1] 284654 0
Primary sponsor type
University
Name
University of New South Wales
Address
High Street
Randwick, NSW 2052
Country
Australia
Secondary sponsor category [1] 283562 0
None
Name [1] 283562 0
Address [1] 283562 0
Country [1] 283562 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286649 0
HREC University of New South Wales
Ethics committee address [1] 286649 0
High Street
Randwick, NSW 2052
Ethics committee country [1] 286649 0
Australia
Date submitted for ethics approval [1] 286649 0
28/11/2011
Approval date [1] 286649 0
Ethics approval number [1] 286649 0

Summary
Brief summary
Overweight and obesity can result in impaired or high glucose levels and aberrant vascular function, which leads to metabolic syndrome (MetS), pre-diabetic (PD), or type 2 diabetes. Early detection of impaired glucose levels in overweight/obese individuals is desirable to prevent the likelihood of disease progression. Thus, the purpose of this study, is firstly to identify early markers, such as impaired/high glucose level and aberrant vascular function in overweight/obese individuals, and secondly, to examine the acute effect of aerobic exercise on those early markers. It is expected that acute exercise will normalize vascular function aberration in MetS and PD individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33737 0
Address 33737 0
Country 33737 0
Phone 33737 0
Fax 33737 0
Email 33737 0
Contact person for public queries
Name 16984 0
Yati Boutcher
Address 16984 0
School of Medical Sciences
Faculty of Medicine
University of New South Wales
High Street, Randwick, NSW 2052
Country 16984 0
Australia
Phone 16984 0
+61-2-9385 2419
Fax 16984 0
Email 16984 0
[email protected]
Contact person for scientific queries
Name 7912 0
Yati Boutcher
Address 7912 0
School of Medical Sciences
Faculty of Medicine
University of New South Wales
High Street, Randwick, NSW 2052
Country 7912 0
Australia
Phone 7912 0
+61-2-9385 2419
Fax 7912 0
Email 7912 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.