None listed
Conditions
Interventions
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.
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
30 Years to 60 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed