The Journal of the AMA has recently published the results of a study titled "Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes: A Randomized Controlled Trial" (JAMA, 2008;299(3):316-323).
In this study, 60 obese people with recent-onset T2DM were randomized to receive either surgery called laparoscopic adjustable gastric banding (LAGB), or conventional medical therapy for their diabetes. Requirements included age between 20 and 60 years, body mass index of 30 to 40, diagnosis of diabetes within the previous 2 years, no evidence of diabetic kidney or eye disease, and able to understand and comply with the study process. The primary end points of the study related to glycemic control at 2 years after randomization.
Although the publication talks modestly about "conventional therapy," I should point out that the care given to the group that didn't get surgery was indeed excellent. According to the report, the Conventional-Therapy Program "delivered best available medical practice for the treatment, education, and follow-up of patients with type 2 diabetes. Patients had open access to a general physician, dietitian, nurse, and diabetes educator and had visits with at least 1 team member every 6 weeks throughout the 2 years. Medical therapies, including pharmaceutical agents, were determined by an experienced diabetologist on an individual basis. Lifestyle modification programs were individually structured to reduce energy intake, to reduce intake of fat ... and to encourage intake of low glycemic index and high-fiber foods. [Extensive ] physical activity advice [was given]. Lifestyle was the primary approach to weight loss, but very low-calorie diets and medications were discussed with all patients and used after consultation with the dietitian or general physician if the patient expressed a desire to use additional measures."
Several of the randomized patients dropped out during the study. One patient randomized to surgery withdrew from the study on the evening prior to scheduled operation and did not agree to be further followed up. Of the 30 people who were randomized to conventional therapy, four withdrew: three withdrew within the first month after randomization, and one withdrew 4 months after randomization.
Adverse events in the surgical group that were described included:
* One patient had the band removed on day 15 due to band intolerance.
* One patient developed a superficial wound infection over the access port site two weeks after it was placed, which resolved with intravenous antibiotics.
* Two patients developed gastric pouch enlargement, both at 10 months after placement, and were treated with nonurgent laparoscopic revisional surgery to remove and replace their bands.
* Other adverse events reported included postoperative febrile episodes in one patient. No cause was found, and the fever resolved. A minor hypoglycemic episode occurred in one patient and gastrointestinal tract intolerance to metformin in another.