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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12605000395639
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
14/09/2005
Date last updated
1/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improvements in insulin resistance caused by weight loss interventions
Scientific title
The effects of very-low calorie diet vs gastric bypass surgery on the metabolic profile of obese patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin resistance 499 0
Diabetes 500 0
Condition category
Condition code
Metabolic and Endocrine 579 579 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty volunteers will be randomised to receive either very-low calorie diet (VLCD)/Optifast or normal feeding regime prior to gastric bypass surgery. Twenty of these volunteers will be randomised to receive VLCD/Optifast by nasogastric tube for six days after surgery. Changes in insulin resistance will be measured by an insulin tolerance test before and after each intervention.
Intervention code [1] 361 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 672 0
Rates of decline for plasma glucose and free fatty acids will be calculated from the insulin tolerance test and compared . This is the measure of insulin resistance.
Timepoint [1] 672 0
Before and after VLCD and gastric bypass
Secondary outcome [1] 1379 0
Body composition will be assessed using whole-body Dual-X-Ray Absorptiometry (DEXA).
Timepoint [1] 1379 0
This will allow accurate measurement of total fat mass and fat-free mass before VLCD and/or surgery and after six days VLCD and/or post-surgery.

Eligibility
Key inclusion criteria
Patients presenting for gastric bypass and,BMI >35
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant known heart disease; significant renal disease; known liver disease; Type 1 diabetes; and,Type 2 diabetes for more than 5 years.

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)
Numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using MS Excel 2003.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
9/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 167 0
New Zealand
State/province [1] 167 0

Funding & Sponsors
Funding source category [1] 629 0
Charities/Societies/Foundations
Name [1] 629 0
Wellington medical research foundation
Country [1] 629 0
New zealand
Funding source category [2] 630 0
Hospital
Name [2] 630 0
The Wakefield clinic
Country [2] 630 0
New zealand
Primary sponsor type
Hospital
Name
The Wakefield clinic
Address
Country
New Zealand
Secondary sponsor category [1] 516 0
None
Name [1] 516 0
Nil
Address [1] 516 0
Country [1] 516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1763 0
Wakefield Hospital
Ethics committee address [1] 1763 0
Ethics committee country [1] 1763 0
Australia
Date submitted for ethics approval [1] 1763 0
Approval date [1] 1763 0
Ethics approval number [1] 1763 0
Ethics committee name [2] 1764 0
The Wakefield Gastroenterology Centre
Ethics committee address [2] 1764 0
Ethics committee country [2] 1764 0
Australia
Date submitted for ethics approval [2] 1764 0
Approval date [2] 1764 0
Ethics approval number [2] 1764 0
Ethics committee name [3] 1765 0
The Wakefield GE Research Institute
Ethics committee address [3] 1765 0
Ethics committee country [3] 1765 0
Australia
Date submitted for ethics approval [3] 1765 0
Approval date [3] 1765 0
Ethics approval number [3] 1765 0

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

Contacts
Principal investigator
Name 36390 0
Address 36390 0
Country 36390 0
Phone 36390 0
Fax 36390 0
Email 36390 0
Contact person for public queries
Name 9550 0
Mr Richard S Stubbs
Address 9550 0
Wakefield Gastroenterology Centre
Rintoul Street
Newtown
Private Bag 7909
Wellington 6039
Country 9550 0
New Zealand
Phone 9550 0
+64 4 3818110
Fax 9550 0
+64 4 3818111
Email 9550 0
[email protected]
Contact person for scientific queries
Name 478 0
Mr Richard S Stubbs
Address 478 0
Wakefield Gastroenterology Centre
Rintoul Street
Newtown
Private Bag 7909
Wellington 6039
Country 478 0
New Zealand
Phone 478 0
+64 4 3818110
Fax 478 0
+64 4 3818111
Email 478 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.