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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12606000188538
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
Does the respiratory function of obese individuals retrun to normal following surgically-induced weight reduction?
Scientific title
Does the respiratory function of obese individuals retrun to normal following surgically-induced weight reduction?
Universal Trial Number (UTN)
Trial acronym
SCARF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1161 0
Respiratory function 1162 0
Condition category
Condition code
Diet and Nutrition 1246 1246 0 0
Obesity
Respiratory 1247 1247 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
This is an observational study on subjects who are undergoing gastric banding for obesity - the initial visit will take place before surgery and the follow-up visit will take place 6 months later.. The study itself has no interventions. Study subjects will be matched with controls and they will have a one off visit around the time of the 6 month follow up for the surgery patient.
Intervention code [1] 1028 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1682 0
Respiratory function (both static and under exercise) in both those undergoing surgery and controls
Timepoint [1] 1682 0
Measurements will be made before and 6 months after surgery
Primary outcome [2] 1683 0
Body fat distribution as measured by Dual Energy X-ray Absorptiometry (DEXA) in both those undergoing surgery and controls
Timepoint [2] 1683 0
Measurements will be made before and 6 months after surgery
Primary outcome [3] 1684 0
Anthropometry in both those undergoing surgery and controls
Timepoint [3] 1684 0
Measurements will be made before and 6 months after surgery
Secondary outcome [1] 3021 0
None
Timepoint [1] 3021 0

Eligibility
Key inclusion criteria
Any subjects listed for gastric banding will be approached.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The only exclusion criteria are if there are any contraindications to the testing being performed, e.g. epilepsy and methacholine challenge.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 315 0
New Zealand
State/province [1] 315 0

Funding & Sponsors
Funding source category [1] 1361 0
University
Name [1] 1361 0
University of Otago Research Grant
Country [1] 1361 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] 1202 0
None
Name [1] 1202 0
There are none
Address [1] 1202 0
Country [1] 1202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2720 0
Respiratory research unit, Dunedin hospital
Ethics committee address [1] 2720 0
Ethics committee country [1] 2720 0
Australia
Date submitted for ethics approval [1] 2720 0
Approval date [1] 2720 0
Ethics approval number [1] 2720 0
LRS/06/02/009

Summary
Brief summary
The study will compare respiratory function at rest and exercise in patients undergoing gastric banding for obesity. They will be compared to similar weight individuals who do not have surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35464 0
Address 35464 0
Country 35464 0
Phone 35464 0
Fax 35464 0
Email 35464 0
Contact person for public queries
Name 10217 0
Dr Tim Sutherland
Address 10217 0
Respiratory Research Unit, Department of Medical and Surgical Sciences, Dunedin Hospital, PO BOx 913, Dunedin
Country 10217 0
New Zealand
Phone 10217 0
+64 3 474 0999 ext 8785
Fax 10217 0
Email 10217 0
[email protected]
Contact person for scientific queries
Name 1145 0
Professor Robin Taylor
Address 1145 0
Respiratory Research Unit Department of Medical and Surgical Sciences Dunedin Hospital PO BOx 913 Dunedin
Country 1145 0
New Zealand
Phone 1145 0
+64 3 474 0999 ext 8785
Fax 1145 0
Email 1145 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.