Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Context: Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial. Objective: The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D. Design: This was designed as a prospective, randomized clinical trial. Setting: The setting was two Harvard Medical School-affiliated academic institutions. Interventions and Participants: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21–65 years with body mass index of 30–45 kg/m2, T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA1c) ≥ 6.5% on antihyperglycemic medication(s). Main Outcome Measure: The proportion meeting the prespecified primary glycemic endpoint, defined as HbA1c < 6.5% and fasting glucose < 7.0 mmol/L at 12 months, on or off medication. Results: After randomization, five participants did not undergo the surgica...