None listed
Conditions
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.
Interventions
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed