Effect of Social Vulnerability on Efficacy of Bariatric Surgery Versus Medical and Lifestyle Intervention for Type 2 Diabetes: Analysis of the ARMMS-T2D Consortium of Randomized Trials.
Academic Article
Overview
abstract
BACKGROUND: Social determinants of health (SDOH) can affect metabolic health. OBJECTIVE: To determine the effect of social vulnerability on the comparative effectiveness of metabolic bariatric surgery or medical and lifestyle intervention on glycemia and weight outcomes in people with type 2 diabetes (T2D). DESIGN: Analysis of the effect modification of baseline Area Deprivation Index (ADI; a metric of social vulnerability) on longitudinal outcomes between randomized treatment groups using linear mixed-effects models. (ClinicalTrials.gov: NCT02328599). SETTING: 4 U.S. academic centers. PARTICIPANTS: 258 participants with T2D enrolled in 4 randomized controlled trials of surgical versus medical management and a longitudinal observational follow-up study. MEASUREMENTS: ADI linked to ZIP code data at randomization; weight loss and hemoglobin A1c (HbA1c) level at the end of the active intervention period (7 to 12 years). RESULTS: Baseline characteristics were well balanced between the surgical and medical therapy groups after adjustment for study site and stratification by high versus low ADI. Surgery was more effective than medical therapy in reducing HbA1c level among persons with high ADI (net difference, -1.29% [95% CI, -1.95% to -0.63%]) and those with low ADI (net difference, -0.95% [CI, -1.29% to -0.62%]). Surgery was also more effective than medical therapy at producing weight loss across ADIs, with respective net differences of -10.6% (CI, -15.2% to -5.9%) for high ADI and -13.3% (CI, -15.7% to -10.9%) for low ADI. The interaction between ADI and intervention group was not significant for either HbA1c (P = 0.37) or weight loss (P = 0.31). LIMITATIONS: Small sample size; parent trials were not designed to address effect modification by ADI. CONCLUSION: Surgery was superior to medical therapy for people with T2D regardless of social deprivation. This study did not detect statistically significant differences in the comparative advantage of surgery over medical therapy by ADI. PRIMARY FUNDING SOURCE: National Institutes of Health.
