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

这份合同是关于糖尿病心血管风险控制行动(ACCORD)临床试验中研究分配的干预措施终止后的试验后观察跟踪研究。新的ACCORD后续(Accordion)主要研究将确定ACCORD期间在死亡率、心血管疾病(CVD)事件和微血管疾病方面的任何差异是持续存在还是随着时间的推移而变化，以及是否出现其他差异。此外，后续将检查关键临床变量的模式，包括安全参数，以及它们与临床事件的关联。 在手风琴方面，将继续根据ACCORD审判进行后续分研究。具体地说，手风琴-心灵认知后续研究的目的是进一步阐明2型糖尿病的强化治疗如何影响大脑功能。特别是，来自这项后续研究的数据将更仔细地检查所观察到的脑结构变化最终是否以及如何影响持续的CF下降。队列的老龄化、更长的随访期和CF的重复测量也将使我们能够研究糖尿病相关因素对大脑的纵向影响，并调查这些因素如何与年龄较大的人相互作用，导致更糟糕的结果。这项子研究还将重点研究慢性肾功能损害如何影响糖尿病的病程，并确定可能传播或缓解脑病理发展的因素。Accordion-HRQL后续研究的目的是确定ACCORD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.