Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study.

Abstract

To compare the effect of Roux-en-Y gastric bypass (RYGB) surgery versus intensive medical diabetes and weight management (IMWM) on clinical and patient-reported outcomes in obese patients with type 2 diabetes. We prospectively randomized 38 obese patients with type 2 diabetes (15 male and 23 female, with mean ± SD weight 104 ± 16 kg, BMI 36.3 ± 3.4 kg/m², age 52 ± 6 years, and HbA_1c 8.5 ± 1.3% [69 ± 14 mmol/mol]) to laparoscopic RYGB (<i>n</i> = 19) or IMWM (<i>n</i> = 19). Changes in weight, HbA_1c, cardiovascular risk factors (UKPDS risk engine), and self-reported health status (the 36-Item Short-Form [SF-36] survey, Impact of Weight on Quality of Life [IWQOL] instrument, and Problem Areas in Diabetes Survey [PAID]) were assessed. After 3 years, the RYGB group had greater weight loss (mean -24.9 kg [95% CI -29.5, -20.4] vs. -5.2 [-10.3, -0.2]; <i>P</i> < 0.001) and lowering of HbA_1c (-1.79% [-2.38, -1.20] vs. -0.39% [-1.06, 0.28] [-19.6 mmol/mol {95% CI -26.0, -13.1} vs. -4.3 {-11.6, 3.1}]; <i>P</i> < 0.001) compared with the IMWM group. Changes in cardiometabolic risk for coronary heart disease and stroke were all more favorable in RYGB versus IMWM (<i>P</i> < 0.05 to <i>P</i> < 0.01). IWQOL improved more after RYGB (<i>P</i> < 0.001), primarily due to subscales of physical function, self-esteem, and work performance. SF-36 and PAID scores improved in both groups, with no difference between treatments. A structural equation model demonstrated that improvement in overall quality of life was more strongly associated with weight loss than with improved HbA_1c and was manifest by greater improvements in IWQOL than with either SF-36 or PAID. Three years after randomization to RYGB versus IMWM, surgery produced greater weight loss, lower HbA_1c, reduced cardiovascular risk, and improvements in obesity-related quality of life in obese patients with type 2 diabetes.