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J B Dixon
Dr J B Dixon, Monash University Medical School, Melbourne, Victoria, Australia; john.dixon@med.monash.edu.au
STUDY DESIGN
Design:
randomised controlled trial.
Allocation:
unclear concealment.*
Blinding:
unblinded.*
STUDY QUESTION
Setting:
University Obesity Research Center in Melbourne, Victoria, Australia.
Patients:
60 participants 20–60 years of age (mean age 47 y, 53% women) who had a body mass index of 30–40 kg/m2, had been diagnosed with type 2 diabetes within the previous 2 years, and did not have renal impairment or diabetic retinopathy. Exclusion criteria were type 1 diabetes, diabetes secondary to a specific disease, or previous bariatric surgery; medical problems such as mental impairment, drug or alcohol addiction, recent major vascular events, internal malignancy, or portal hypertension; contraindications to either study intervention; and failure to attend 2 initial information visits.
Intervention:
LAGB using the pars flaccida technique plus CT (n = 30) or CT alone (n = 30). CT comprised access to a …
Footnotes
Source of funding: Allergan Health (unrestricted grant to Monash University and provided gastric bands) and Applied Medical (provided laparoscopic parts).