Three Year Outcomes after Metabolic Surgery or Medical/Lifestyle Intervention: The ARM MS-T2D Trial

There is limited Level-1 evidence from well-powered randomized controlled trials (RCTs) examining improved glycemic control after metabolic surgery in patients with type 2 diabetes (T2D) and obesity. ARMMS-T2D is a multi-center consortium conducting a follow-up study of 4 merged RCTs in 256 patients with baseline Class 1-3 obesity and T2D, randomly assigned to metabolic surgery (MS;Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric banding) or intensive Medical/Lifestyle Intervention (MLI). Three years after randomization, T2D remission rates were higher after MS than MLI (37.5%, 60/160 vs. 2.6%, 2/76, respectively, P<0.001). Adjusting for treatment allocation, baseline HbA1c, and T2D duration, the probability of remission with MS was 41.6% (95% CI, 29.6-58.3%) compared to 1% (95% CI, 0.2-4.0%) with MLI (P<0.001). MS patients experienced greater reductions than MLI in HbA1c (-1.9±2.0 vs. -0.1±2.0%, P<0.001) and fasting plasma glucose (-52 [-105, 5] vs. -12 [-48, 26] mg/dL, P<0.001). Compared to MLI, MS patients had greater reductions in BMI (-22.0±9.4 vs. -4.8±7.9 kg/m2, P<0.001) and waist circumference (-17.5 ±10.2 vs. -2.1±9.6 cm, P<0.001), greater increases in HDL-C (35.5± 27.6 vs. 9.1±24.1, P<0.001), greater reductions in triglycerides (-33[-52, -2] vs. -10 [-36, 14] P<0.001), and similar changes in LDL-C (9.5±41.5 vs. 4.2±31.6 mg/dL). MS and MLI rendered similar reductions in albumin/creatinine ratio (-2 [-13, 1] vs. 0 [-4, 4]) and eGFR (-3.1±16.7 vs. -4.6±19.5 mL/min/1.73 m2). Also, MS patients required fewer medications for diabetes, hypertension, and dyslipidemia compared to MLI (P<0.001). In summary, this 3-year follow-up of the largest cohort of patients randomized to metabolic surgery vs. non-surgical treatment demonstrates that surgery is more effective than intensive medical/lifestyle therapy in achieving extended diabetes remission, BMI reduction, and improved metabolic disease biomarkers while reducing medication requirements. Disclosure: J. P. Kirwan: None. J. M. Jakicic: Advisory Panel;Self;Naturally Slim, Spark360, Weight Watchers International, Inc. M. Patti: Consultant;Self;Cello Health, Fractyl Laboratories, Inc., MBX, Poxel SA, WGBH, Other Relationship;Self;Xeris Pharmaceuticals, Inc., Research Support;Self;Dexcom, Inc. K. Wolski: None. P. Schauer: Advisory Panel;Self;GI Dynamics, Keyron, Mediflix, Persona, Consultant;Self;Ethicon, Inc., Medtronic, Research Support;Self;Ethicon, Inc., Medtronic, Pacira. A. Courcoulas: None. D. E. Cummings: Advisory Panel;Self;DyaMx, GI Dynamics. A. Goldfine: Employee;Self;Novartis AG. S. Kashyap: Advisory Panel;Self;Fractyl Laboratories, Inc., GI Dynamics. D. C. Simonson: Stock/Shareholder;Spouse/Partner;Phase V Technologies, Inc. D. Arterburn: None. W. F. Gourash: None. A. H. Vernon: None. Funding: National Institutes of Health (DK114156);Ethicon Endo-Surgery;Covidien [ABSTRACT FROM AUTHOR] Copyright of Diabetes is the property of American Diabetes Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)