Abstract
Introduction: A lack of effective interventions remains a major clinical gap in cardiovascular disease (CVD) prevention for individuals with type 2 diabetes (T2D) and high glycated hemoglobin (HbA1c). Our objective was to determine whether the effect of an intensive lifestyle intervention (ILI) on CVD prevention differed by baseline HbA1c among Action for Health in Diabetes (Look AHEAD) trial participants. Hypothesis: ILI will be associated with differential risk for CVD by HbA1c. Methods: Look AHEAD randomized 5145 adults, aged 45-76 years, with T2D and overweight/obesity, to ILI or a control of diabetes support and education (DSE) for a median of 9.6 years. ILI focused on weight loss through decreased caloric intake and increased physical activity. We assessed the parent trial’s pre-specified primary CVD outcome. We assessed for additive (Poisson regression) and multiplicative (Cox proportional hazards) heterogeneity of intervention effects on CVD risk by HbA1c adjusting for stratified randomization and using intention to treat analysis. Results: Baseline HbA1c ranged from 4.4% to 14.5% (mean 7.3, SD 1.2). We observed additive and multiplicative heterogeneity of effects (all p<0.001) between ILI and HbA1c on CVD risk (Figure). Compared to DSE, ILI was associated with lower risk for CVD for HbA1c quintiles 1 and 2. The “ILI-CVD” association changed direction at HbA1c=7.7%; ILI was associated with higher risk of CVD than DSE within HbA1c quintile 5 (and when continuous, HbA1c ≥8.7%). Conclusion: Among adults with T2D and overweight/obesity, the effect of a lifestyle intervention on CVD risk differed by HbA1c. There is a critical need to identify effective CVD prevention strategies for individuals with T2D and high HbA1c.
Published Version
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