Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000159651
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
16/08/2005
Date last updated
2/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of weight loss on Type 2 Diabetes: a prospective randomized controlled trial of best practice medical management versus the placement of the Lap-Band System on HbA1c concentration.
Scientific title
The effect of weight loss on Type 2 Diabetes: a prospective randomized controlled trial of best practice medical management versus the placement of the Lap-Band System on HbA1c concentration.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 254 0
Condition category
Condition code
Metabolic and Endocrine 286 286 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty patients who have been diagnosed as having Type 2 diabetes within the last two years will be randomly allocated to having Lap-Band placement and community best practice diabetic care or to community best practice diabetic care alone. Patient follow up will continue for 2 years from randomization.
Intervention code [1] 172 0
Treatment: Surgery
Comparator / control treatment
Community best practice diabetic care alone.
Control group
Active

Outcomes
Primary outcome [1] 333 0
The biochemical assessment of glycaemic control of Type 2 diabetes using HbA1c concentration
Timepoint [1] 333 0
At 2 years from randomisation
Secondary outcome [1] 744 0
Biochemical assessment of fasting plasma lipids
Timepoint [1] 744 0
At 12 and 24 months.
Secondary outcome [2] 745 0
Assessment of blood pressure
Timepoint [2] 745 0
At 12 and 24 months.
Secondary outcome [3] 746 0
Medication used to treat hyperglycaemia and hypertension
Timepoint [3] 746 0
At 12 and 24 months
Secondary outcome [4] 747 0
Morbidity and mortality associated with diabetes, obesity or treatment of these conditions
Timepoint [4] 747 0
At 24 months
Secondary outcome [5] 749 0
The achievement and sustainability of weight loss.
Timepoint [5] 749 0
At 24 months
Secondary outcome [6] 750 0
Additional biochemical endpoints will include indirect measures of insulin resistance and beta cell function using the homeostatic model assessment using fasting plasma glucose and C-peptide concentrations, liver function tests, and an assessment of renal function and presence of microalbuminuria. T
Timepoint [6] 750 0
At 12 and 24 months
Secondary outcome [7] 751 0
The costs of all diabetes and obesity related treatments including surgery and medications would be assessed.
Timepoint [7] 751 0
At 24 months
Secondary outcome [8] 752 0
Other clinical comorbidities including obstructive sleep apnoea and ovulatory dysfunction would also be assessed.
Timepoint [8] 752 0
At 24 months
Secondary outcome [9] 753 0
Quality of life and functional status will be assessed using the SF36, Multi-Dimensional Body-Self Relations questionnaire and the Beck Depression Inventory, and employment details.
Timepoint [9] 753 0
At 12 and 24 months
Secondary outcome [10] 754 0
The costs of managing diabetes and obesity in both groups will be recorded and the side effects and/or complications of any treatment of diabetes or obesity will be noted.
Timepoint [10] 754 0
At 24 months

Eligibility
Key inclusion criteria
Patients will have a BMI greater than 30 and less than 40kg/m2, have been diagnosed with Type 2 diabetes within the last two years, have no evidence of renal impairment, microalbuminuria or retinopathy, be able to understand the options and study requirements and to comply with the either arm of the study, and be willing to be randomized.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwillingness to accept the randomization process, history of previous abdominal surgery which would potentially preclude laparascopic placement of the band, a history of previous obesity surgery, any contraindication to Lap-Band placement, medical issues which contraindicated 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, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure) , systemic lupus erythematosis or other auto-immune disease, direct hypothalamic damage as a cause of obesity, inability to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes, Type 1 diabetes or diabetes secondary to specific diseases foe example haemochromatosis 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)
Intervention recorded and stored in numbered, sealed opaque envelopes organized and maintained by staff member not involved in patient care or scheduling and opened in sequence as randomized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were block randomized in groups with equal numbers in both treatment arms. The sequence within blocks was determined by drawing allocation out of a hat.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 339 0
University
Name [1] 339 0
Centre for Obesity Research and Education (CORE) Monash University
Country [1] 339 0
Australia
Funding source category [2] 340 0
Commercial sector/Industry
Name [2] 340 0
Inamed Health
Country [2] 340 0
United States of America
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE)
Address
Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 270 0
None
Name [1] 270 0
none
Address [1] 270 0
Country [1] 270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1286 0
The Avenue Hospital, Melbourne
Ethics committee address [1] 1286 0
Ethics committee country [1] 1286 0
Australia
Date submitted for ethics approval [1] 1286 0
Approval date [1] 1286 0
07/08/2002
Ethics approval number [1] 1286 0
Trial 033
Ethics committee name [2] 1287 0
Monash University SCERH
Ethics committee address [2] 1287 0
Ethics committee country [2] 1287 0
Australia
Date submitted for ethics approval [2] 1287 0
Approval date [2] 1287 0
04/09/2003
Ethics approval number [2] 1287 0
2003/459MC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36082 0
Address 36082 0
Country 36082 0
Phone 36082 0
Fax 36082 0
Email 36082 0
Contact person for public queries
Name 9361 0
Ms Julie Playfair
Address 9361 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9361 0
Australia
Phone 9361 0
+61 3 99030721
Fax 9361 0
+61 3 95103365
Email 9361 0
[email protected]
Contact person for scientific queries
Name 289 0
Associate Professor John Dixon
Address 289 0
School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill Vic 3168
Country 289 0
Australia
Phone 289 0
+61 3 9501 2431
Fax 289 0
+61 3 8575 2233
Email 289 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.