Three Year Outcomes after Metabolic Surgery or Medical/Lifestyle Intervention: The ARMMS-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.)

Bariatric and metabolic surgery during and after the COVID-19 pandemic: DSS recommendations for management of surgical candidates and postoperative patients and prioritisation of access to surgery.

The coronavirus disease 2019 pandemic is wreaking havoc on society, especially health-care systems, including disrupting bariatric and metabolic surgery. The current limitations on accessibility to non-urgent care undermine postoperative monitoring of patients who have undergone such operations. Furthermore, like most elective surgery, new bariatric and metabolic procedures are being postponed worldwide during the pandemic. When the outbreak abates, a backlog of people seeking these operations will exist. Hence, surgical candidates face prolonged delays of beneficial treatment. Because of the progressive nature of obesity and diabetes, delaying surgery increases risks for morbidity and mortality, thus requiring strategies to mitigate harm. The risk of harm, however, varies among patients, depending on the type and severity of their comorbidities. A triaging strategy is therefore needed. The traditional weight-centric patient-selection criteria do not favour cases based on actual clinical needs. In this Personal View, experts from the Diabetes Surgery Summit consensus conference series provide guidance for the management of patients while surgery is delayed and for postoperative surveillance. We also offer a strategy to prioritise bariatric and metabolic surgery candidates on the basis of the diseases that are most likely to be ameliorated postoperatively. Although our system will be particularly germane in the immediate future, it also provides a framework for long-term clinically meaningful prioritisation.