Tuesday 28 April 2015

Adjustable Gastric Band Surgery or Medical Management in Patients with Type 2 Diabetes

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Adjustable Gastric Band Surgery or Medical Management in Patients with Type 2 Diabetes
Published Online: April 24, 2015
Abstract Context:
Recommendations for surgical compared with lifestyle and pharmacologic based approaches for type 2 diabetes (T2D) management remain controversial.
Objective:
Comparing laparoscopic adjustable gastric band (LAGB) to an intensive diabetes medical and weight management (IMWM) program for T2D.
Design:
Prospective, randomized clinical trial.
Setting:
Two Harvard Medical School affiliated academic institutions.
Interventions and Participants:
12-month randomized trial comparing LAGB (n=23) versus IMWM (n=22), in persons aged 21-65 years, BMI 30-45 kg/m2, T2D diagnosed more than 1-year prior, and HbA1c ≥6.5 and fasting glucose<7.0 mmol/L at 12-months, on-or-off medication.
Results:
After randomization 5 participants did not undergo their surgical intervention. Of the 40 initiating intervention (22M/18F; age 51±10 years; BMI 36.5±3.7 kg/m2; diabetes duration 9±5 years; HbA1c 8.2±1.2 on insulin) the proportion meeting the primary glycemic endpoint was achieved in 33 of IMWM (P=0.457). HbA1c reduction was similar between groups at both 3- and 12-months (-1.2±0.3 versus -1.0±0.3%, P=0.496). Weight loss was similar at 3- but greater 12-months post-LAGB (-13.5±1.7 versus -8.5±1.6 kg, P=0.027). Systolic blood pressure reductions were greater after IMWM than LAGB while changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient reported health status assessed using Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between

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