ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) STUDY- C

本合同适用于控制糖尿病心血管风险措施（雅阁）临床试验中研究分配的干预措施终止后的试验后观察性随访研究。新的雅阁随访（ACCORDION）主要研究将确定在雅阁期间观察到的死亡率，心血管疾病（CVD）事件和微血管疾病的任何差异是否持续存在或随时间变化，以及是否出现其他差异。此外，随访将检查关键临床变量的模式，包括安全性参数及其与临床事件的相关性。 在ACCORDION下，将继续进行在雅阁试验下进行的后续子研究。具体而言，ACCORDION-MIND认知后续子研究的目的是进一步描述2型糖尿病强化治疗如何影响脑功能。特别是，这次随访的数据将更密切地研究观察到的大脑结构变化是否以及如何最终影响CF的持续下降。队列的老龄化，更长的随访和CF的重复测量也将允许研究糖尿病相关因素对大脑的纵向影响，以及调查这些因素如何与老年相结合，相互作用，导致更差的结果。该子研究还将关注CF损伤如何前瞻性地影响糖尿病的病程，并确定可能传播或减轻脑病理学发展的因素。ACCORDION-HRQL后续子研究的目的是确定雅阁研究中测试的干预措施的长期成本效益。

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.