None listed
Conditions
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.
Interventions
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed