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Health-Related Quality of Life and Health Utility after Metabolic/Bariatric Surgery vs. Medical/Lifestyle Intervention in Individuals with Type 2 Diabetes and Obesity: The ARMMS-T2D Study

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posted on 2025-02-04, 16:35 authored by Donald C. Simonson, William F. Gourash, David E. Arterburn, Bo Hu, Sangeeta R. Kashyap, David E. Cummings, Mary-Elizabeth Patti, Anita P. Courcoulas, Ashley H. Vernon, John M. Jakicic, Sarah Kirschling, Ali Aminian, Philip R. Schauer, John P. Kirwan

Objective: Type 2 diabetes and obesity are associated with reduced health-related quality of life (HRQoL) and health utility (HU), but long-term effects of metabolic/bariatric surgery (MBS) compared to medical/lifestyle intervention (MLI) on these outcomes are unclear. Research Design and Methods: We studied 228 individuals with type 2 diabetes and obesity randomized to MBS (Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric band; n=152) or MLI (n=76) in the ARMMS-T2D study. HRQoL (SF-36, including Physical Component Score [PCS] and Mental Component Score [MCS]) and HU (SF-6D) were measured annually up to 12 years. Results: At baseline, participant’s age was 49.2±8.0 years, 68.4% were female, BMI was 36.3±3.4 kg/m², and HbA1c was 8.7±1.6%. PCS improved significantly more in MBS vs. MLI over 12 years (+2.37±0.53 vs. -0.95±0.73; difference = 3.32±0.85, p<0.001). MBS was associated with better general health (p<0.001), physical function (p=0.001) and vitality (p=0.003). Reduction in BMI was greater after MBS vs. MLI (p<0.001) and correlated with improved PCS (r=-0.43, p<0.001). Change in PCS was not associated with change in HbA1c. MCS changed minimally from baseline and was similar between MBS and MLI during follow-up (-0.21±0.61 vs. -0.89±0.84; difference = 0.68±0.97, p=0.48). Improvements in HU were greater in MBS vs. MLI over 12 years (+0.02±0.01 vs. -0.01±0.01; difference = 0.03±0.01, p=0.003). Conclusions: Metabolic surgery produces sustained weight loss and improves PCS, general health, physical function, vitality, and health utility in individuals with type 2 diabetes and obesity compared to medical therapy up to 12 years after intervention.

Funding

ARMMS-T2D was supported by cooperative agreement U01 DK114156 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The parent trials were funded as follows: STAMPEDE was supported by an investigator-initiated grant from Ethicon Endo-Surgery, in-kind support from LifeScan, and NIDDK Grant R01 DK089547; SLIMM-T2D was funded by NIDDK grants RC1 DK086918, R56 DK095451, and P30 DK036836, the Herbert Graetz Fund at Joslin Diabetes Center, and Patient-Centered Outcomes Research Institute grant CE-1304-6756, and in-kind support from LifeScan, Nestle, and Novo Nordisk; TRIABETES was funded by NIDDK grants RC1DK086037 and R01 DK095128, and by subsidization of the surgical procedures by Magee-Womens Hospital of the University of Pittsburgh Medical Center; CROSSROADS was funded by NIDDK grant R01 DK089528 and grants from the Group Health Research Institute and Group Health Foundation, and in-kind support from Informed Medical Decisions Foundation. All 4 studies above received bridge funding from Covidien (now Medtronic) and Ethicon in preparation for the current NIH-funded observational follow-up and analysis.

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