Can dynamic pupillography and/or spectral analysis of heart rate variability prov

心率变异性的动态瞳孔描记和/或频谱分析可以证明

• 批准号: 7334274
• 负责人: Solomon Tesfaye
• 金额: $ 15.46万
• 依托单位: SHEFFIELD TEACHING HOSPITALS NHS FDN TRU
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7334274
• 关键词: Arrhythmia; Autonomic Dysfunction; Biological Markers; Cardiovascular system; Clinical; Complications of Diabetes Mellitus; Cross-Sectional Studies; Diabetes Mellitus; Diabetic Angiopathies; Diabetic Autonomic Neuropathy; Disease; Early Diagnosis; Heart Rate; Intervention; Invasive; Lead; Measures; Morbidity - disease rate; Myocardial Ischemia; Natural History; Numbers; Range; Rate; Reflex action; Research; Risk; Screening procedure; Staging; Standardization; Standards of Weights and Measures; Study Subject; Techniques; Testing; Variant; autonomic neuropathy; cardiovascular risk factor; healthy volunteer; mortality; novel; outcome forecast; prospective; pupillography; respiratory

DESCRIPTION (provided by applicant): Diabetic autonomic neuropathy (DAN) is a serious complication of diabetes and carries up to a five-fold increased risk of mortality. This high mortality rate is related in large part to silent myocardial ischemia, cardiac arrhythmias, and cardio-respiratory instability. Despite its relationship to an increased risk of cardiovascular mortality and its association with significant morbidity, the importance of DAN is not fully appreciated and it frequently goes undiagnosed. A major reason for this is that whilst severe symptomatic DAN is relatively uncommon, many people have sub-clinical or asymptomatic DAN. Early detection of this disorder might lead to a better prognosis for people with diabetes, by the deployment of interventions which will slow or possibly even reverse its progression. However, unlike other microvascular complications, there is currently no simple test or biomarker that would allow for screening large numbers of people. It has also limited the study of the natural history of the disorder and the impact of interventions in large-scale prospective trials. Dynamic pupillography and spectral analysis of heart rate variability are safe, noninvasive, quick and easy techniques that may allow for more widespread assessment and earlier detection of autonomic dysfunction both in the research and clinical setting. They result in a variety of different measures that may act as novel biomarkers for different types and stages of autonomic neuropathy. The aim of this cross-sectional study is to assess the usefulness of these different techniques by comparing them with standard cardiovascular reflex tests for the assessment of autonomic neuropathy. It will comprise of 5 groups (n=20 in each) consisting of: people with diabetes and (1) symptomatic autonomic neuropathy; (2) asymptomatic autonomic neuropathy; (3) sub-clinical autonomic neuropathy; (4) no autonomic neuropathy and (5) healthy volunteers. Also, analysis of the results will provide the range of variation for the analysed parameters among the different groups of subjects studied and allow for refinement and standardisation of these techniques.

描述（由申请人提供）：糖尿病自主神经病变（DAN）是糖尿病的一种严重并发症，死亡风险增加五倍。这种高死亡率在很大程度上与无症状心肌缺血、心律失常和心肺不稳定有关。尽管 DAN 与心血管死亡风险增加以及显着的发病率相关，但 DAN 的重要性尚未得到充分认识，并且经常未被诊断。造成这种情况的主要原因是，虽然有严重症状的 DAN 相对罕见，但许多人患有亚临床或无症状的 DAN。早期发现这种疾病可能会通过采取干预措施来减缓甚至逆转其进展，从而为糖尿病患者带来更好的预后。然而，与其他微血管并发症不同，目前没有简单的测试或生物标志物可以对大量人群进行筛查。它还限制了对该疾病的自然史以及大规模前瞻性试验中干预措施影响的研究。心率变异性的动态瞳孔描记术和频谱分析是安全、无创、快速且简单的技术，可以在研究和临床环境中更广泛地评估和更早地检测自主神经功能障碍。它们产生了多种不同的测量结果，可以作为不同类型和阶段的自主神经病的新型生物标志物。这项横断面研究的目的是通过将这些不同技术与用于评估自主神经病变的标准心血管反射测试进行比较来评估这些技术的有用性。它将由 5 组（每组 20 人）组成：糖尿病患者和 (1) 有症状的自主神经病变； (2)无症状的自主神经病变； (3)亚临床自主神经病变； (4) 无自主神经病变且 (5) 健康志愿者。此外，结果分析将提供不同研究对象组之间分析参数的变化范围，并允许这些技术的细化和标准化。