None listed
Conditions
Interventions
Obese patients will be randomized to either the medical or surgical group. The medical arm will receive treatment with a VLCD plus ongoing individualized care encompassing other obesity drugs as determined and behaviour modification programs. The surgical arm will receive treatment with the Lap-Band System, a laparoscopic adjustable gastric band. Patients will be followed for two years from randomization.
Sponsors
Centre for Obesity Research and Education (CORE)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
BMI 30-35, have identifiable problems either medical, physical or psychosocial with this level of obesity, be able to understand the options, the potential benefits and risks, and be able to comply with the requirements of each program.
Exclusion criteria
Lack of acceptance of the randomization process, history of previous abdominal surgery which would potentially preclude the laparoscopic placement of the band, medical issues which contra-indicated either arm of the study including 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, inability to understand the risks, unrealistic expectation of benefits or likelihood of failure to comply with the follow up requirements of either program.
Outcome results
None listed