Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000548730
Ethics application status
Approved
Date submitted
8/05/2013
Date registered
15/05/2013
Date last updated
2/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight loss to prevent diabetes in obese people with impaired fasting glucose
Scientific title
The effect of weight loss following laparoscopic adjustable gastric banding on the rate of progression from impaired fasting glucose to diabetes
Secondary ID [1] 282475 0
Nil
Universal Trial Number (UTN)
U1111-1142-8385
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 289100 0
diabetes mellitus 289101 0
Condition category
Condition code
Metabolic and Endocrine 289438 289438 0 0
Diabetes
Metabolic and Endocrine 289439 289439 0 0
Metabolic disorders
Diet and Nutrition 289464 289464 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Laparoscopic adjustable gastric band surgery - we will observe effects on weight and rates of progression to diabetes over 5 years
Intervention code [1] 287124 0
Not applicable
Comparator / control treatment
AusDiab data of community-dwelling Australians with impaired fasting glucose recruited in 1999/2000 and followed for 5 years (Med J Aust. 2003 May 5;178(9):427-32)
Control group
Historical

Outcomes
Primary outcome [1] 289542 0
Rates of diabetes incidence (defined as fasting glucose>7.0mmol/L), stratified to weight loss
Timepoint [1] 289542 0
5 years following gastric band surgery
Secondary outcome [1] 302705 0
nil
Timepoint [1] 302705 0
nil

Eligibility
Key inclusion criteria
Impaired fasting glucose (5.6-6.9mmol/L), obese (BMI>30kg/m2) and undertaking gastric band surgery at a Melbourne centre
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Standard: Fisher exact and chi-square, with multivariable analysis to identify confounding variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/1995
Actual
1/10/1995
Date of last participant enrolment
Anticipated
31/08/2007
Actual
31/08/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 978 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 6873 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 287254 0
University
Name [1] 287254 0
Monash University
Country [1] 287254 0
Australia
Primary sponsor type
Individual
Name
Prof Paul O'Brien
Address
Centre for Obesity Research and Education
Alfred Centre
Commercial Rd
Prahran Vic 3181
Country
Australia
Secondary sponsor category [1] 286008 0
None
Name [1] 286008 0
Address [1] 286008 0
Country [1] 286008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289234 0
Monash University HREC
Ethics committee address [1] 289234 0
Monash University
Wellington Rd
Clayton, Vic, 3800
Ethics committee country [1] 289234 0
Australia
Date submitted for ethics approval [1] 289234 0
01/01/2011
Approval date [1] 289234 0
12/05/2011
Ethics approval number [1] 289234 0
CF11/0310

Summary
Brief summary
Weight loss following gastric band surgery, defined as % excess weight loss (poor - <20%, moderate 20-45% or good >45%), will be correlated to rates of progression from impaired fasting glucose to diabetes. These rates will be compared to those of AusDiab participants from a similar time period.
Trial website
Trial related presentations / publications
Public notes
We obtained retrospective ethics approval. This enabled us to study results from people who first presented to our centre in 1995.

Contacts
Principal investigator
Name 39910 0
Dr John Wentworth
Address 39910 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville, Vic, 3050
Country 39910 0
Australia
Phone 39910 0
+61 422992891
Fax 39910 0
Email 39910 0
[email protected]
Contact person for public queries
Name 39911 0
Dr John Wentworth
Address 39911 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville, Vic, 3050
Country 39911 0
Australia
Phone 39911 0
+61 422992891
Fax 39911 0
Email 39911 0
[email protected]
Contact person for scientific queries
Name 39912 0
Dr John Wentworth
Address 39912 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville, Vic, 3050
Country 39912 0
Australia
Phone 39912 0
+61 422992891
Fax 39912 0
Email 39912 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.