Chicago—A randomized controlled trial of obese patients with type 2 diabetes found that those undergoing Roux-en-Y gastric bypass surgery had greater weight loss and sustained improvement in hemoglobin A1c (HbA1c) levels at 1 year compared with a group that underwent an intensive diabetes and medical weight management program. After a year of treatment, both groups showed improvement in self-reported physical and mental health status and reduced problems associated with diabetes management.
Donald C. Simonson, MD, the study’s lead author, presented the results at the ADA meeting in an oral abstract session. The National Institutes of Health and Covidien funded the study.
Although studies have shown that losing weight improves patient-reported outcomes among type 2 diabetes patients, Dr. Simonson noted that few prospective randomized trials have compared weight loss due to medical management with weight loss associated with bariatric surgery.
In this study, the patients randomized 38 obese patients with type 2 diabetes in a 1:1 ratio to receive an intensive diabetes and medical weight management program or undergo Roux-en-Y gastric bypass surgery performed laparoscopically with standard postoperative care and nutritional support. Of the patients, 15 were males (9 in the management group and 6 in the surgery group) and 23 were females (10 in the management group and 13 in the surgery group).
Patients had a body mass index (BMI) between 30 kg/m2 and 45 kg/m2, type 2 diabetes for at least 1 year, an HbA1c level of at least 6.5% on insulin or oral hypoglycemic agents, no clinically significant nephropathy, retinopathy, or macrovascular disease, and no contraindication to gastric bypass surgery or the diabetes and weight management program.
The management program consisted of a 12-week, multidisciplinary program for intensive weight and diabetes management. After 12 weeks, patients participated in the program once a month for 1 year. During the diabetes medication component, the authors increased or added drugs such as metformin and glucagon-like peptide-1 agonists and reduced insulins and sulfonylureas and other drugs that may contribute to weight gain. Patients also had a structured modified dietary intervention, cognitive behavioral intervention, and a graded, balanced, and individualized exercise intervention.
The authors obtained measurements at baseline, when patients had lost 10% of their weight or after 3 months if they had not lost 10%, and at 12 months. Measurement tools included the Short-Form 36 (SF-36) survey, the Problem Areas in Diabetes (PAID) scale, and the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Questionnaire.
After 3 months or when patients lost 10% of their body weight, there was a significantly greater decrease in BMI in the surgery group compared with the management group (P<.001). All 19 patients in the surgical group and 7 patients in the management group achieved 10% weight loss before 3 months. At 12 months, there was also a significantly greater decrease in BMI for patients in the surgery group compared with the management group (P<.001).
The change in HbA1c levels from baseline to 3 months was similar in both groups, but the change was significantly more favorable in patients in the surgery group at 12 months (P<.001). After 12 months, patients in the management group had an HbA1c level similar to baseline, while the surgery group had a mean reduction of approximately 2.0%.
After 3 months, patients in the management group had a significant improvement in SF-36 physical health scores from baseline. Patients in the surgery group had a slightly worse score at 3 months compared with baseline, which Dr. Simonson explained happened because many of the patients were still in the postoperative period. After 12 months, the improvement in physical health was evident in both groups. At 3 and 12 months, both groups showed improvement in SF-36 mental health scores.
In addition, both groups improved comparably after 3 months as assessed by the PAID scale and the IWQOL-Lite measurement. At 12 months, the management group had a significantly greater improvement compared with the surgery group as assessed by PAID (P<.05) and by IWQOL-Lite (P<.01).