235-OR: Quality of Life and Health Utility 12 Years after Randomization to Bariatric Surgery vs. Medical Therapy in Patients with Type 2 Diabetes and Obesity—The ARMMS-T2D Study

Introduction & Objective: T2D and obesity are associated with reduced quality of life (QoL) and health utility (HU), but long-term effects of metabolic/bariatric surgery (MBS) vs. a medical/lifestyle intervention (MLI) on these outcomes are not known. Methods: We studied 228 patients with T2D and obesity who were randomized to MBS (RYGB, gastric band, or sleeve gastrectomy; n = 152) vs. MLI (n = 76) in the ARMMS-T2D study. QoL (SF-36; including Physical Component Score [PCS], Mental Component Score [MCS], and 8 scale scores) and HU (SF-6D) were measured annually for 12 yrs. Results: At baseline, age = 49.2 ± 8.0 yrs., 68% were female, 68% White, BMI = 36.3 ± 3.4 kg/m², HbA1c = 8.7 ± 1.6%. PCS improved significantly in MBS at year 1, remained higher vs. MLI over 12 yrs. (p < 0.001), and was associated with better general health (p < 0.001), physical function (p = 0.001), energy (p = 0.003), and reduced pain (p = 0.03). Change in BMI was greater after MBS vs. MLI (-18.6 ± 12.4% vs. -11.4 ± 10.9%, p < 0.001), and significantly correlated with change in PCS (r = -0.43, p < 0.001). In contrast, MCS (p = 0.14), emotional well-being (p = 0.53), role emotional (p = 0.43), and social functioning (p = 0.11) did not change from baseline and were similar between groups over 12 yrs. Changes in PCS and MCS were not associated with change in HbA1c. Among patients taking insulin at baseline, those who discontinued insulin had higher PCS (p < 0.001) over time. HU was moderately low at baseline (0.69 ± 0.08) and did not change significantly in either group during 12 yrs. Conclusions: MBS produced sustained weight loss that correlated with improved PCS, including better general health, physical function, energy, and less pain. PCS improved more in patients who discontinued insulin. There were no significant differences between groups over time in MCS or in HU. These differences may help patients with T2D and obesity make informed decisions about their best treatment options. Disclosure D.C. Simonson: Stock/Shareholder; Phase V Technologies, Inc. Advisory Panel; GI Windows. W.F. Gourash: None. D. Arterburn: None. B. Hu: None. S.R. Kashyap: Research Support; Fractyl Health, Inc. Advisory Panel; GI Dynamics. Research Support; Janssen Pharmaceuticals, Inc. M. Patti: Research Support; Dexcom, Inc. Consultant; Hanmi Pharm. Co., Ltd., MBX Biosciences. Other Relationship; Fractyl Health, Inc. Consultant; AstraZeneca, Spruce Biosciences. P. Schauer: Research Support; Ethicon, Inc. Other Relationship; Ethicon, Inc. Research Support; Medtronic. Other Relationship; Medtronic, Novo Nordisk. Advisory Panel; Lilly Diabetes, GI Dynamics, Heron. Stock/Shareholder; Mediflix, SE Healthcare. Other Relationship; Klens. Advisory Panel; Persona, Keyron. Stock/Shareholder; Metabolic Health International LTD. D.E. Cummings: None. A. Courcoulas: Research Support; Allurion, Eli Lilly and Company. A. Aminian: Research Support; Medtronic. Consultant; Medtronic, Ethicon, Inc. Research Support; Ethicon, Inc. Advisory Panel; Eli Lilly and Company. J.M. Jakicic: Research Support; Epitomee. Advisory Panel; Wondr Health. Consultant; Education Initiatives, Inc. A.H. Vernon: None. J.P. Kirwan: None. Funding National Institutes of Health (U01 DK114156)