Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000107527
Ethics application status
Approved
Date submitted
25/01/2006
Date registered
23/03/2006
Date last updated
23/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight Loss & Cardiovascular Risk in Type 2 Diabetes Study
Scientific title
Effect of energy restriction and exercise training on flow-mediated dilatation and oxidative stress in sedentary overweight and obese subjects with type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 1071 0
Obesity 1072 0
Condition category
Condition code
Metabolic and Endocrine 1151 1151 0 0
Diabetes
Diet and Nutrition 1152 1152 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weekdietary weight loss (energy restriction) & aerobic exercise training program
Intervention code [1] 865 0
Lifestyle
Comparator / control treatment
12 week dietary weight loss program (energy restriction)
Control group
Placebo

Outcomes
Primary outcome [1] 1547 0
1. Endothelial function (flow mediated dilatation)
Timepoint [1] 1547 0
Measured at week 0 (baseline) and week 12 (end of intervention).
Primary outcome [2] 1548 0
2. Cardiovascular disease risk markers
Timepoint [2] 1548 0
Measured at week 0 (baseline) and week 12 (end of intervention).
Secondary outcome [1] 2794 0
n/a
Timepoint [1] 2794 0

Eligibility
Key inclusion criteria
BMI greater than 27, less than 40Type 2 diabetes.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Beta-blocker or glucocortcoids medicationdietary supplementsregular physcial exercise.

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)
Volunteers will be randomly allocated by computer generated sequence to study treatments.This allocation will be concealed from research staff by a locked computer file.However, due to the nature of the treatments being investigated, the sequence allocation cannot be consealed from the volunteers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
volunteers will be initially blocked matched into 2 groups based on age, body mass index and gender prior to randomisation by computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
6/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1256 0
Charities/Societies/Foundations
Name [1] 1256 0
diabetes aust research trust
Country [1] 1256 0
Australia
Funding source category [2] 1257 0
Government body
Name [2] 1257 0
CSIRO Human Nutrition
Country [2] 1257 0
Australia
Funding source category [3] 1258 0
Other Collaborative groups
Name [3] 1258 0
Aust technology network
Country [3] 1258 0
Australia
Primary sponsor type
Government body
Name
CSIRO & Diabetes Aust research trust
Address
Country
Australia
Secondary sponsor category [1] 1115 0
Other Collaborative groups
Name [1] 1115 0
Aust technology network
Address [1] 1115 0
Country [1] 1115 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2593 0
CSIRO & University of South Australia
Ethics committee address [1] 2593 0
Ethics committee country [1] 2593 0
Australia
Date submitted for ethics approval [1] 2593 0
Approval date [1] 2593 0
Ethics approval number [1] 2593 0

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

Contacts
Principal investigator
Name 35589 0
Address 35589 0
Country 35589 0
Phone 35589 0
Fax 35589 0
Email 35589 0
Contact person for public queries
Name 10054 0
Dr Grant Brinkworth
Address 10054 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10054 0
Australia
Phone 10054 0
+61 8 83038830
Fax 10054 0
+61 8 8303 8899
Email 10054 0
grant.brinkworth@csiro.au
Contact person for scientific queries
Name 982 0
Dr Grant Brinkworth
Address 982 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 982 0
Australia
Phone 982 0
+61 8 83038830
Fax 982 0
+61 8 8303 8899
Email 982 0
grant.brinkworth@csiro.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
No additional documents have been identified.