This contract is for the post-trial observational follow-up study after termination of study-assigned interventions in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trial. The new ACCORD Follow-on (ACCORDION) Main Study will determine whether any differences seen during ACCORD in mortality, cardiovascular disease (CVD) events, and microvascular diseases persist or change over time and whether other differences emerge. In addition, the follow-up will examine patterns of key clinical variables, including safety parameters, and their association with clinical events. Under ACCORDION, follow-on sub-studies conducted under the ACCORD trial will be continued. Specifically, the aim of the ACCORDION-MIND Cognition follow-on sub-study is to further delineate how intensive therapy for type 2 diabetes affects brain function. In particular, the data from this follow-up will more closely examine whether and how observed changes in brain structure ultimately impact ongoing decline in CF. The aging of the cohort, longer follow-up and repeated measures of CF will also allow the study of longitudinal effects of diabetes-related factors on the brain, and the investigation of how these factors, in combination with older age, interact, leading to worse outcomes. The substudy will also focus on how impairment in CF prospectively affects the course of diabetes, and identify factors that may propagate, or mitigate, development of cerebral pathology.
The aim of the ACCORDION-HRQL follow-on sub-study is to determine the long-term cost-effectiveness of the interventions that were tested in the ACCORD study.