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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000180
ACTR Number: ACTRN12605000159651
Trial Status: Registered
Date Submitted: 11/08/2005
Date Registered: 16/08/2005

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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.
ANZCTR registration 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.
Secondary ID: 
UTN:
Trial acronym:

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

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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:Treatment: surgery 
Comparator / control treatment: Community best practice diabetic care alone.
Control group: Active

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Primary outcome:The biochemical assessment of glycaemic control of Type 2 diabetes using HbA1c concentration 
Timepoint:At 2 years from randomisation 
Secondary outcome 1:Biochemical assessment of fasting plasma lipids 
Timepoint:At 12 and 24 months. 
Secondary outcome 2:Assessment of blood pressure 
Timepoint:At 12 and 24 months. 
Secondary outcome 3:Medication used to treat hyperglycaemia and hypertension 
Timepoint:At 12 and 24 months 
Secondary outcome 4:Morbidity and mortality associated with diabetes, obesity or treatment of these conditions 
Timepoint:At 24 months 
Secondary outcome 5:The achievement and sustainability of weight loss. 
Timepoint:At 24 months 
Secondary outcome 6: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:At 12 and 24 months 
Secondary outcome 7:The costs of all diabetes and obesity related treatments including surgery and medications would be assessed. 
Timepoint:At 24 months 
Secondary outcome 8:Other clinical comorbidities including obstructive sleep apnoea and ovulatory dysfunction would also be assessed. 
Timepoint:At 24 months 
Secondary outcome 9: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:At 12 and 24 months 
Secondary outcome 10: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:At 24 months 

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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
Gender: Both males and females
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the 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.
Describe the 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)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 4
Anticipated or actual date of first participant enrolement: 1/02/2003
Target sample size: 60
Recruitment status: Closed: follow-up complete

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Funding source 1:University 
Name:Centre for Obesity Research and Education (CORE) Monash University 
Address:Commercial Road Melbourne Vic 3004 
Country:Australia 
Funding source 2:Commercial sector/Industry 
Name:Inamed Health 
Address:5540 Ekwill Street Santa Barbara CA 93111 
Country:United States of America 
Primary sponsor: University
Name: Centre for Obesity Research and Education (CORE)
Address: Commercial Road Melbourne Vic 3004
Country: Australia
Secondary sponsor:None 
Name:none 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:The Avenue Hospital, Melbourne 
Address:The Avenue Windsor Vic 3181 
Country:Australia 
Date of approval:7/08/2002 
HREC Number:Trial 033 
Ethics Committee name 2:Monash University SCERH 
Address:Building 3D, Clayton Campus Wellington Road Clayton Vic 
Country:Australia 
Date of approval:4/09/2003 
HREC Number:2003/459MC 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list: Presentation: American Diabetes Association meeting, Chicago, June 2007. Abstract Number 1834-P-"Randomised Trial of Surgically-induced Weight Loss for Obeses subjects with Type-2 Diabetes". Publication: Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M: Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. Jama 299:316-323, 2008

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Contact person for public queries
Name: Ms Julie Playfair
Address: Centre for Obesity Research and Education (CORE) Monash University Medical School Alfred Hospital Commercial Road Melbourne VIC 3004
Country: Australia
Tel: +61 3 99030721
Fax: +61 3 95103365
Email: julie.playfair@med.monash.edu.au

Contact person for scientific queries
Name: Associate Professor John Dixon
Address: School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill Vic 3168
Country: Australia
Tel: +61 3 9501 2431
Fax: +61 3 8575 2233
Email: john.dixon@med.monash.edu.au

Contact person responsible for updating information
Name: Mrs Maureen Dixon
Address: School of Primary Health Care
Building 1, 270 Ferntree Gully Road
Notting Hill 3168
Country: Australia
Tel: +61 3 8575 2273
Fax: +61 3 8575 2233
Email: maureen.dixon@med.monash.edu.au
   
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