Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000319279
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
21/05/2009
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Control of Diabetes through Weight Loss in Indigenous Diabetes
Scientific title
The effect of lapband surgery on weight loss in diabetic Indigenous Australians.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 4577 0
Condition category
Condition code
Metabolic and Endocrine 4872 4872 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic gastric banding surgery is a minimally invasive surgery lasting 60-90 minutes, in which a band is fastened around the upper stomach to create a small pouch which restricts the amount of food that can be consumed.
Intervention code [1] 4340 0
Treatment: Surgery
Comparator / control treatment
Active group. Standard care: health education and self administered questionnaire to assess their perception of diabetes. It would take approximately 30 minutes to complete. Following, a discussion with them would be held (lasting 2-3 hours) to address their concerns and refresh aspects of diabetes education identified in the questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 5723 0
The central aim of the study is to achieve a substantial and durable weight loss. The principal outcome is the frequency of remission of type 2 diabetes in response to this weight loss. Additional outcomes would include measure of side effects and complications, compliance, acceptability and costs.
Weight loss and frequency of diabetes remission will be measured by clinical assessments (weight lost via full medical history, examination by health professional), collection of tissue/ fluid (blood results indicating diabetes status)
Timepoint [1] 5723 0
Each participant would be engaged in a process of care for their diabetes which would begin with a detailed clinical assessment (including baseline data collection). There would be an operative procedure involving an overnight hospital stay and then data would be collected fortnightly over a two year period.
Secondary outcome [1] 241657 0
Compliance (subjects band compliance and acceptance) - via questionaires, focus groups
Timepoint [1] 241657 0
Data would be collected fortnightly over a two year period.

Eligibility
Key inclusion criteria
Patients must:
-1. Be Indigenous people who suffer obesity and type 2 diabetes
-1. Agree to comply with the procedures of the study including questionnaire assessment
2.Have no history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
3.Be free of medical issues which contra-indicated the proposed treatments. These may include acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, pregnancy or intending to conceive in the next two years, lactation, severe alcohol or drug abuse, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
4.Be able to understand the Lapband (LAGB) procedure and its potential for benefit and risk.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients would be excluded from entry -:
1. If there was lack of acceptance of the procedures of the study including questionnaire assessment
2. If there was a history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
3. If there were medical issues which contra-indicated the proposed treatments. These may include acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, pregnancy or intending to conceive in the next two years, lactation, severe alcohol or drug abuse, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
4. If there was an inability to understand the LapBand (LAGB) procedure and its potential for benefit and risk or were unable to understand or agree to the aftercare process.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2009
Actual
19/11/2009
Date of last participant enrolment
Anticipated
Actual
12/08/2010
Date of last data collection
Anticipated
Actual
20/10/2014
Sample size
Target
210
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4764 0
Self funded/Unfunded
Name [1] 4764 0
Country [1] 4764 0
Primary sponsor type
University
Name
Monash University
Address
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country
Australia
Secondary sponsor category [1] 4302 0
None
Name [1] 4302 0
Address [1] 4302 0
Country [1] 4302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6967 0
Monash University Human Research Ethics Committee (SCERH)
Ethics committee address [1] 6967 0
Human Ethics
Monash Research Office
Building 3E, Room 111
Monash University, Clayton 3800
Ethics committee country [1] 6967 0
Australia
Date submitted for ethics approval [1] 6967 0
Approval date [1] 6967 0
01/05/2009
Ethics approval number [1] 6967 0

Summary
Brief summary
The hypothesis of this study is that the LAGB procedure and the aftercare program would be acceptable and feasible and engender sufficient compliance that a group of Indigenous people with type 2 diabetes will benefit from the weight loss with remission of type 2 diabetes equal to that observed in a Caucasian group of the Melbourne RCT trial. To ascertain success-factors for the LAGB procedure and give appropriate health education with a view of improving their compliance to obtain the hypothesised results the study would assess the perceptions and beliefs of diabetes patients and their health care service providers.

The central aim of the study is to achieve a substantial and durable weight loss. The principal outcome is the frequency of remission of type 2 diabetes in response to this weight loss. Additional outcomes would include measure of side effects and complications, compliance, acceptability and costs.
Trial website
Trial related presentations / publications
O'Brien Paul E. (2015)

The Effect of Weight Loss on Indigenous Australians
with Diabetes: a study of Feasibility, Acceptability
and Effectiveness of Laparoscopic Adjustable Gastric Banding

Obesity Surgery in January ( Vol 26: 45-53).
Public notes

Contacts
Principal investigator
Name 29475 0
Address 29475 0
Country 29475 0
Phone 29475 0
Fax 29475 0
Email 29475 0
Contact person for public queries
Name 12722 0
Kristine Egberts
Address 12722 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 12722 0
Australia
Phone 12722 0
+613 99030686
Fax 12722 0
Email 12722 0
Kristine.Egberts@med.monash.edu.au
Contact person for scientific queries
Name 3650 0
Kristine Egberts
Address 3650 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 3650 0
Australia
Phone 3650 0
+613 99030686
Fax 3650 0
Email 3650 0
Kristine.Egberts@med.monash.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseThe Effect of Weight Loss on Indigenous Australians with Diabetes: a study of Feasibility, Acceptability and Effectiveness of Laparoscopic Adjustable Gastric Banding.2016https://dx.doi.org/10.1007/s11695-015-1733-4
N.B. These documents automatically identified may not have been verified by the study sponsor.