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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12606000189527
Ethics application status
Approved
Date submitted
9/05/2006
Date registered
18/05/2006
Date last updated
18/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
How does body fat distribution effect respiratory function tests?
Scientific title
A non-interventional observational study on the impact of obesity in respiratory function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1163 0
Respiratory function 1164 0
Condition category
Condition code
Diet and Nutrition 1248 1248 0 0
Obesity
Respiratory 1249 1249 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-interventional observational study
Intervention code [1] 1029 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1685 0
Respiratory function tests
Timepoint [1] 1685 0
These are one off observations
Primary outcome [2] 1686 0
Body fat distribution as measured by Dual Energy X-ray Absorptiometry (DEXA)
Timepoint [2] 1686 0
These are one off observations
Secondary outcome [1] 3022 0
None
Timepoint [1] 3022 0

Eligibility
Key inclusion criteria
BMIs from 20 to 42 will be recruited.
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any respiratory disease, atopic individuals, and any conditions where the tests are contraindicated, e.g. epilepsy and methacholine challenge.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 316 0
New Zealand
State/province [1] 316 0

Funding & Sponsors
Funding source category [1] 1362 0
University
Name [1] 1362 0
University of Otago Research Grant
Country [1] 1362 0
New Zealand
Primary sponsor type
Name
we are applying for money from local sources, for example the University of Otago Research Grant
Address
Country
New Zealand
Secondary sponsor category [1] 1203 0
None
Name [1] 1203 0
none
Address [1] 1203 0
Country [1] 1203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2721 0
Respiratory Research Unit, Dunedin Hospital
Ethics committee address [1] 2721 0
Ethics committee country [1] 2721 0
Australia
Date submitted for ethics approval [1] 2721 0
Approval date [1] 2721 0
Ethics approval number [1] 2721 0

Summary
Brief summary
The hypothesis is that obesity has an impact on respiratory function and we aim to quantify this
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35524 0
Address 35524 0
Country 35524 0
Phone 35524 0
Fax 35524 0
Email 35524 0
Contact person for public queries
Name 10218 0
[email protected]
Address 10218 0
Respiratory Research Unit, Department of Medical and Surgical Sciences, Dunedin hospital, PO Box 913, Dunedin
Country 10218 0
New Zealand
Phone 10218 0
+64 3 474 0999 ext 8785
Fax 10218 0
Email 10218 0
[email protected]
Contact person for scientific queries
Name 1146 0
Professor Robin Taylor
Address 1146 0
Respiratory Research Unit Department of Medical and Surgical Sciences Dunedin Hospital PO Box 913 Dunedin
Country 1146 0
New Zealand
Phone 1146 0
+64 3 474 0999 ext 8785
Fax 1146 0
Email 1146 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.