Surgical Treatment of Diabetes: Making a Case for a Pragmatic Approach.

The development of type 2 diabetes mellitus (T2DM) is one of the most serious consequences of weight gain and obesity. Despite an understanding of this association by patients and their physicians, weight loss through diet and exercise, the typical lifestyle modifications recommended to break the yoke of diabetes that hangs on obese individuals, requires intensive interventions that can be difficult to maintain (1, 2). Moreover, lifestyle measures are generally inadequate in patients with severe obesity who are at particularly high risk of developing T2DM and its complications. Although developed primarily to facilitate weight loss, bariatric surgery has been noted to cause marked improvement in diabetes control (3). Emerging data have provided convincing evidence that bariatric surgery can produce rapid, effective, and sustainable remission of T2DM in addition to weight loss and is superior to nonsurgical interventions (3–7). Both the American Diabetes Association (8) and the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery (9) have now expanded their treatment recommendations to include bariatric surgery as an option for individuals with morbid obesity, body mass index (BMI) 40 kg/m or 35 kg/m with comorbid conditions such as T2DM. Recently, the US Food and Drug Administration approved laparoscopic adjustable gastric banding (LAGB) for individuals with BMI of 30–34 kg/m and comorbidities. LAGB is a relatively simple bariatric procedure in which a saline-filled silicon band is fitted around the stomach near the esophageal junction. The level of gastric restriction imposed by the band can be adjusted by infusing saline through a sc port maintaining the desired level of gastric restriction. LAGB is the least invasive of the commonly used bariatric surgical procedures, with a perioperative mortality rate of approximately 0.05% (10). The safety, ease, and greater effectiveness for weight loss than what is usually obtained with lifestyle measures make the rationale for use of LAGB at lower levels of BMI, and raise the possibility of applying this procedure more widely in the treatment of T2DM. The outcomes of two previous randomized controlled studies have demonstrated that subjects receiving LAGB have superior weight loss and improvement in diabetes control relative to those getting medical or lifestyle management (4, 11). In this issue of the JCEM, Ding et al (12) add another study comparing the effectiveness of LAGB to medical/ lifestyle measures for the treatment of T2DM. They conducted a 12-month randomized, controlled, single-center trial comparing 23 diabetic subjects assigned LAGB with 22 subjects given intensive medical and weight management (IMWM) in a structured program based on previous successful regimens. Notably, they recruited diabetic patients without regard to ongoing treatment or duration of disease and with a broad range of diabetic control. In this sense, the study was arguably more pragmatic than some previous trials in that it involved a population reflective of the average diabetes practice. The average BMI for the study group was 36.5 3.7 kg/m; they had been diagnosed with diabetes for 9 5 years (10 6 in the surgery group and 8 4 in the control), and their glycated hemoglobin (HbA1c) was 8.2 1.2%. About 40% of the patients were on insulin (72% in the surgery group and 18% in the IMWM group). After 1 year, the primary endpoint (HbA1c 6.5% and fasting glucose 7.0 mmol/L) was achieved in 33% of the LAGB group and 23% of the IMWM group, a difference that did not differ statistically. HbA1c reduction over the course of the trial was similar between groups ( 1%), but weight loss was greater in the