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Trial registered on ANZCTR


Registration number
ACTRN12609000286246
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
18/05/2009
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight Loss and Type 2 Diabetes: A prospective randomised controlled trial intervention study of best practice medical management versus the additional placement of the Lap-Band System in overweight patients
Scientific title
Weight Loss and Type 2 Diabetes: A prospective randomised controlled trial intervention study of best practice medical management versus the additional placement of the Lap-Band System in overweight patients
Secondary ID [1] 718 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 3692 0
Diabetes Type 2 3693 0
Condition category
Condition code
Metabolic and Endocrine 3858 3858 0 0
Diabetes
Diet and Nutrition 4932 4932 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of the Lap-Band (Laparoscopic Adjustable Gastric Band) by surgery in overweight individuals in the Body Mass Index 25-30 range. This procedure is permanent and patients will be followed for two years after surgery.
Intervention code [1] 3406 0
Treatment: Surgery
Comparator / control treatment
Best practice medical management (optimal standard therapy) is a program of optimal medical treatment. Advice from a diabetes educator and dietician regarding diet, weight loss, movement and exercise, and any behavioral changes will take place 3-monthly. A specialist endocrinologist will manage any medication necessary to control blood sugar levels, high blood pressure and other diabetes related conditions 3-monthly. This advice and education will take the form of one hour sessions 3-monthly for a total of 2 years. Patients with HbA1c>7% at 9 months will be reviewed 6-weekly until 12 months
Control group
Active

Outcomes
Primary outcome [1] 4759 0
Biochemical assessment of glycaemic control of type 2 diabetes (HbA1c, fasting glucose)
Timepoint [1] 4759 0
3,6,9,12,24, and 60
Primary outcome [2] 4760 0
Assessment of co-morbidity control including abnormalities of blood pressure, serum lipids and liver function (via measurement of liver enzymes concentrations)
Timepoint [2] 4760 0
3, 6, 9, 12, 24, and 60
Primary outcome [3] 268957 0
Resolution of diabetes (fasting and 2h glucose following 75g oral glucose <7.1 and <11.1 respectively)
Timepoint [3] 268957 0
months 24 and 60
Secondary outcome [1] 8040 0
Clinical measures related to metabolic syndrome (eg lipids, waist circumference, medication burden, BP)
Timepoint [1] 8040 0
months 3, 6, 9, 12 and 60
Secondary outcome [2] 8041 0
Cost effectiveness - via technical efficiency analysis, which will draw on both the primary data collections from the trial (costs of the intervention; change in weight; cases of diabetes resolved; change in functional status), as well as economic modelling.
Timepoint [2] 8041 0
12 and 60 months
Secondary outcome [3] 241747 0
Weight loss will be measured by Excess weight lost in kilograms (EWL) or Body Mass Index (BMI) points lost
Timepoint [3] 241747 0
months 3, 6, 9, 12 and 60
Secondary outcome [4] 276692 0
insulin and C-peptide response to 25g IV glucose
Timepoint [4] 276692 0
Months 12 and 60

Eligibility
Key inclusion criteria
1. Be between 18 and 65 years of age, 2. Have a body mass index greater than 25 and less than 30 kg/m2. 3. Have been diagnosed with type 2 diabetes in the last 5 years. 4. Be able to understand the options and study requirements and to comply with the requirements of each program. 5. Willing to be randomized.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. If there was lack of acceptance of the randomization process,
2. If there were a history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
3. If there was a history of previous obesity surgery
4. If there were any contraindication to LapBand (LAGB) placement.
5. If there were medical issues which contra-indicated the application of either arm of the study. These would 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, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
6. Systemic lupus erythematosis or other auto-immune disease.
7. Direct hypothalamic damage as a cause of obesity.
8. If they were unable to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes.
9. The patient had type 1 diabetes or diabetes was secondary to specific diseases such as haemachromatosis or chronic pancreatitis.

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)
Initial recruitment into the study would be achieved by a general awareness campaign, which emphasized a study of weight loss on type 2 diabetes in the overweight patient. Interested candidates would be provided with detailed information regarding the problems of diabetes and excess weight on at least two occasions along with detailed information of the two treatment arms of the study.
The eligible patients will be randomly assigned to receive:
(1) a continuing program of medical treatment which will have a conventional program of advice and education regarding eating and exercise and include conventional medical therapy for diabetes and associated conditions (Program 1) or:
(2) the LAGB procedure as an additional intervention (Program 2).
Allocation was achieved via the use of sealed opaque envelopes with the letters A and B enclosed, which corresponded to either the treatment group or control group. This procedure was carried out by a data manager not involved with the study (in any other way)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random assignment will be computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3875 0
University
Name [1] 3875 0
Monash University
Address [1] 3875 0
Wellington Rd
Victoria 3800
Country [1] 3875 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Victoria 3800
Country
Australia
Secondary sponsor category [1] 3479 0
Other
Name [1] 3479 0
Centre for Obesity Research and Education
Address [1] 3479 0
Monash University Medical School
The Alfred Hospital
Commercial Rd
Melbourne, 3004
Victoria
Country [1] 3479 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301951 0
The Avenue Hospital
Ethics committee address [1] 301951 0
40 The Avenue
Windsor VIC 3181
Ethics committee country [1] 301951 0
Australia
Date submitted for ethics approval [1] 301951 0
02/12/2008
Approval date [1] 301951 0
12/01/2009
Ethics approval number [1] 301951 0
0101

Summary
Brief summary
The primary aim of this proposal is to compare LAGB surgery with optimal medical therapy over the period of the 2-year trial. The hypothesis is LAGB provides better results.
Trial website
Trial related presentations / publications
Wentworth JM (2014)
Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.
Lancet Diabetes Endocrinol. 2014 Jul;2(7):545-522014. PMID: 24731535
Public notes

Contacts
Principal investigator
Name 28934 0
Prof Paul O'Brien
Address 28934 0
Centre for Obesity Research and Education
Monash University
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Vic 3004
Country 28934 0
Australia
Phone 28934 0
+61422992891
Fax 28934 0
Email 28934 0
paul.obrien@monash.edu
Contact person for public queries
Name 12091 0
Ms Miss Kristine Egberts
Address 12091 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004
Country 12091 0
Australia
Phone 12091 0
+61 2 9903 0686
Fax 12091 0
Email 12091 0
Kristine.Egberts@med.monash.edu.au
Contact person for scientific queries
Name 3019 0
Ms Miss Kristine Egberts
Address 3019 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004
Country 3019 0
Australia
Phone 3019 0
+61 2 9903 0686
Fax 3019 0
Email 3019 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?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary