Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000089538
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
3/02/2015
Date last updated
7/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term weight and glycaemic outcomes of gastric band surgery in diabetes
Scientific title
Long-term weight and glycaemic outcomes of gastric band surgery in diabetes
Secondary ID [1] 285959 0
nil known
Universal Trial Number (UTN)
U1111-1166-0224
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293891 0
Type 2 diabetes 293892 0
Condition category
Condition code
Metabolic and Endocrine 294195 294195 0 0
Diabetes
Diet and Nutrition 294357 294357 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
10-year follow-up following gastric band surgery to effect weight loss in obese people.
Intervention code [1] 290934 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293984 0
Body weight by calibrated digital scales
Timepoint [1] 293984 0
10 years
Secondary outcome [1] 312284 0
HbA1c, measured by routine biochemical assay
Timepoint [1] 312284 0
10 years
Secondary outcome [2] 312501 0
Quality of life, assessed using SF-36 questionnairre
Timepoint [2] 312501 0
10 years
Secondary outcome [3] 312632 0
Medication use, assessed by patient interview
Timepoint [3] 312632 0
10 years
Secondary outcome [4] 312633 0
lipid profile measured by routine biochemical assay
Timepoint [4] 312633 0
10 years

Eligibility
Key inclusion criteria
Had type 2 diabetes when undergoing gastric band surgery between 2003 and 2005 at the Centre for Bariatric Surgery, Melbourne
Minimum age
18 Years
Maximum age
75 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
We will use Prism v6 and R software to analyse data. Categorical and continuous data will be compared by Fisher’s exact and t-test where appropriate. For regression analyses, the significance of each variable will be established via analysis of deviance with a t-test.
Based on our previous experience, a sample size of at least 50 will be sufficient to produce robust data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2015
Actual
1/01/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
31/12/2015
Date of last data collection
Anticipated
Actual
31/07/2016
Sample size
Target
100
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3321 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 9102 0
3001 - Melbourne

Funding & Sponsors
Funding source category [1] 290541 0
University
Name [1] 290541 0
Monash CORE
Country [1] 290541 0
Australia
Primary sponsor type
Individual
Name
John Wentworth
Address
Monash CORE
Level 6 Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 289233 0
None
Name [1] 289233 0
Address [1] 289233 0
Country [1] 289233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292189 0
Monash University HREC
Ethics committee address [1] 292189 0
Monash Research Office
Building 3d
Monash University
Victoria 3800
Australia
Ethics committee country [1] 292189 0
Australia
Date submitted for ethics approval [1] 292189 0
Approval date [1] 292189 0
10/01/2014
Ethics approval number [1] 292189 0
CF13/3299  -­-  2013001716

Summary
Brief summary
This is an analysis of weight and diabetes outcomes ten years after gastric band surgery to treat obesity. Participants will be identified from a clinical database, which will provide baseline data. Ten-year data will be collected prospectively during routine clinic attendance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53990 0
Dr John Wentworth
Address 53990 0
Monash University CORE
Level 6 Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 53990 0
Australia
Phone 53990 0
+61 3 93452555
Fax 53990 0
Email 53990 0
[email protected]
Contact person for public queries
Name 53991 0
Dr John Wentworth
Address 53991 0
Monash University CORE
Level 6 Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 53991 0
Australia
Phone 53991 0
+61 3 93452555
Fax 53991 0
Email 53991 0
[email protected]
Contact person for scientific queries
Name 53992 0
Dr John Wentworth
Address 53992 0
Monash University CORE
Level 6 Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 53992 0
Australia
Phone 53992 0
+61 3 93452555
Fax 53992 0
Email 53992 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
SourceTitleYear of PublicationDOI
EmbaseDiabetes Outcomes More than a Decade Following Sustained Weight Loss After Laparoscopic Adjustable Gastric Band Surgery.2018https://dx.doi.org/10.1007/s11695-017-2944-7
N.B. These documents automatically identified may not have been verified by the study sponsor.