ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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

Condition category

Condition code

Metabolic and Endocrine

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]

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]

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]

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]

Compliance (subjects band compliance and acceptance) - via questionaires, focus groups

Timepoint [1]

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?

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

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (SCERH)

Ethics committee address [1]

Human Ethics
Monash Research Office
Building 3E, Room 111
Monash University, Clayton 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/05/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Kristine Egberts

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

Phone

+613 99030686

Fax

Kristine.Egberts@med.monash.edu.au

Contact person for scientific queries

Name

Kristine Egberts

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

Phone

+613 99030686

Fax

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

Source	Title	Year of Publication	DOI
Embase	The Effect of Weight Loss on Indigenous Australians with Diabetes: a study of Feasibility, Acceptability and Effectiveness of Laparoscopic Adjustable Gastric Banding.	2016	https://dx.doi.org/10.1007/s11695-015-1733-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically