History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial
Year: 2020
Type: article
Abstract: OBJECTIVE: To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). METHODS: This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. RESULTS: Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. CONCLUSIONS: Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.
Source: Obesity
DOI: 10.1002/oby.22676
Authors: Cora E. Lewis, John P. Bantle, Alain G. Bertoni, George Blackburn, Frederick L. Brancati, George A. Bray, Lawrence J. Cheskin, Jeffrey M. Curtis, Caitlin Egan, Mary Evans, John P. Foreyt, Siran Ghazarian, Bethany Barone Gibbs, Stephen P. Glasser, Edward W. Gregg, Helen P. Hazuda, Louise Hesson, James O. Hill, Edward S. Horton, Van S. Hubbard, John M. Jakicic, Robert W. Jeffery, Karen C. Johnson, Steven E. Kahn, Abbas E. Kitabchi, Dalane Kitzman, William C. Knowler, Edward Lipkin, Sara Michaels, Maria G. Montez, David M. Nathan, Ebenezer Nyenwe, Jennifer Patricio, Anne Peters, Xavier Pi‐Sunyer, Henry Pownall, David M. Reboussin, Donna H. Ryan, Thomas A. Wadden, Lynne E. Wagenknecht, Holly Wyatt, Rena R. Wing, Susan Z. Yanovski
Institutions: University of Alabama at Birmingham, University of Minnesota, Wake Forest University, Beth Israel Deaconess Medical Center, Johns Hopkins University, Pennington Biomedical Research Center, St. Joseph's Hospital and Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases, Miriam Hospital, Baylor College of Medicine, University of Southern California, University of Pittsburgh, Centers for Disease Control and Prevention, The University of Texas at San Antonio Health Science Center, University of Pennsylvania, University of Colorado Anschutz, Joslin Diabetes Center, University of Tennessee Health Science Center, University of Washington, VA Puget Sound Health Care System, American Indian Center, Massachusetts General Hospital, St. Luke's-Roosevelt Hospital Center, Columbia University
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: New York City Department of Health and Mental Hygiene, National Institutes of Health, Centers for Disease Control and Prevention, National Institute on Aging, National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Center on Minority Health and Health Disparities, National Center for Research Resources, Office of Research on Women's Health
Awards: G1442900148, G1559150778, G1561916549, G1625418467, G1789861183, G2067731686, G2115812462, G2247787434, G2279102038, G2519210884, G2784927490, G3033840998, G3085877500, 05/16 Action for Health in Diabetes Extension Study - Research Project, G3237517486, General Clinical Research Center, Harvard Clinical and Translational Science Center (UL1), General Clinical Research Center, General Clinical Research Center, GENERAL CLINICAL RESEARCH CENTER, G3728863030, University of Pittsburgh Clinical and Translational Science Institute, G4623107666, G474757791, 09/16 Action for Health in Diabetes Extension Study Research Project, 08/16 Action for Health in Diabetes Extension Study Research Project, 07/16 Action for Health in Diabetes Extension Study Research Project, G5800301348, General Clinical Research Center, G640327682, G6543313332, G7244940528, G7376939847, Obesity/Nutrition Research Center, 12/16 Action for Health in Diabetes Extension Study Research Project, G860149444, Pittsburgh Older Americans Independence Center, Diabetes Research Center, UAB Nutrition Obesity Research Center (NORC), G903953877, G955307958
OpenAlex ID: W2997256356
