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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% on anti-hyperglycemic medication(s).
Main Outcome Measure:

The proportion meeting the pre-specified 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 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%; 40% on insulin) the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB group and 23% 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 groups.
Conclusions:

LAGB versus a multidisciplinary intensive diabetes and weight management program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in context of other factors, such as personal preference, when selecting treatment options with obese type 2 diabetes patients. Longer duration studies are important to understand emergent differences.
Trial Registration:

Clinicaltrials.gov NCT01073020
Affiliations

1Harvard Medical School, Boston, MA, 02115;
2Joslin Diabetes Center, Boston, MA, 02215;
3Brigham and Women’s Hospital, Boston, MA, 02115
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