1226-P: Three Year Outcomes after Metabolic Surgery or Medical/Lifestyle Intervention: The ARMMS-T2D Trial
Authors: KIRWAN JOHN P. , COURCOULAS ANITA , CUMMINGS DAVID E. , GOLDFINE ALLISON , KASHYAP SANGEETA , SIMONSON DONALD C. , ARTERBURN DAVID , GOURASH WILLIAM F. , VERNON ASHLEY H. , JAKICIC JOHN M. , PATTI MARY-ELIZABETH , WOLSKI KATHERINE , SCHAUER PHILIP 
Published: June 2021

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&lt;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&lt;0.001). MS patients experienced greater reductions than MLI in HbA1c (-1.9±2.0 vs. -0.1±2.0%, P&lt;0.001) and fasting plasma glucose ( -52 [-105, 5] vs. -12 [-48, 26] mg/dL, P&lt;0.001). Compared to MLI, MS patients had greater reductions in BMI (-22.0±9.4 vs. -4.8±7.9 kg/m2, P&lt;0.001) and waist circumference (-17.5 ±10.2 vs. -2.1±9.6 cm, P&lt;0.001), greater increases in HDL-C (35.5± 27.6 vs. 9.1±24.1, P&lt;0.001), greater reductions in triglycerides (-33[-52, -2] vs. -10 [-36, 14] P&lt;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&lt;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