ESRD Endocrinopathy and Daily Dialysis

描述(由申请人提供)：需要维持透析的终末期肾病(ESRD)影响着40万美国人，预计在未来几十年，受影响的成年人数量将呈指数级增长。ESRD与各种内分泌和代谢异常、身体成分变化、尿毒症症状、较低的生活质量和功能状态以及较高的心血管和死亡风险有关。然而，透析频率和剂量的改变能在多大程度上改变这些不良结果尚不清楚。NIDDK赞助的频繁血液透析网络(FHN)研究是一项随机试验，旨在评估在12个月的时间里，频繁(每周6次)和常规(每周3次)血液透析是否会导致心血管结构和功能、与健康相关的生活质量、身体功能、身体成分、认知功能、心理健康、营养状况、高血压、高磷血症和其他结果的临床相关差异。我们建议补充FHN，在基线和随访期间对靶向内分泌和代谢因素进行额外测量，以确定与ESRD相关的内分泌疾病是否与不良结果相关；透析频率是否改善这些内分泌疾病；以及内分泌功能的变化是否与临床结果的变化相关。这项拟议的研究将对与终末期肾病相关的内分泌和代谢异常及其与相关临床和以患者为中心的结果的关系产生新的见解。我们的三个具体目标是：在FHN研究中登记的250名ESRD维持性血液透析患者中：目标1：确定ESRD患者中垂体和甲状腺相关激素和矿物质代谢异常的发生率和相关性，以及它们与生活质量、身体和认知功能、身体成分和心血管指标的关系。目的2：评估频繁和常规血液透析对12个月内内分泌功能变化的影响，以及这些变化是否有助于不同的健康相关结果。目的：评价频繁血液透析与常规血液透析对12个月靶向激素及矿物质代谢和炎症相关因子变化的影响，以及这些变化是否与左心室肥厚的差异有关。 公共卫生相关性： 项目简介这是一项针对日常血液透析与常规血液透析的频繁血液透析网络试验的拟议辅助研究。这项研究的主要目标是确定与终末期肾病相关的内分泌疾病的特征，它们随透析频率的变化，以及这些变化与健康相关结果的关系。

DESCRIPTION (provided by applicant): Abstract End stage renal disease (ESRD) requiring maintenance dialysis affects >400,000 Americans and the number of affected adults is projected to exponentially increase in the coming decades. ESRD is associated with various endocrine and metabolic abnormalities, body composition changes, uremic symptoms, lower quality of life and functional status, and higher cardiovascular and mortality risk. However, the degree to which changes in dialysis frequency and dose can alter these adverse outcomes are not known. The NIDDK-sponsored Frequent Hemodialysis Network (FHN) Study is a randomized trial to evaluate whether frequent (6 times per week) vs. conventional (3 times per week) hemodialysis over a 12- month period leads to clinically relevant differences in cardiovascular structure and function, health-related quality of life, physical function, body composition, cognitive function, mental health, nutritional status, hypertension, hyperphosphatemia, and other outcomes. We propose to complement the FHN with additional measurements of targeted endocrine and metabolic factors at baseline and during follow-up to determine if the endocrinopathies associated with ESRD are associated with adverse outcomes; if frequency of dialysis improves these endocrinopathies; and if changes in endocrine function are associated with changes in clinical outcomes. The proposed study will yield novel insights into the endocrine and metabolic abnormalities associated with ESRD and their relation to relevant clinical and patient-centered outcomes. Our three Specific Aims are: Among up to 250 persons with ESRD on maintenance hemodialysis enrolled into the FHN Study: Aim 1: To characterize the prevalence and correlates of abnormalities in pituitary and thyroid- related hormones and mineral metabolism and their association with quality of life, physical and cognitive function, body composition and cardiovascular measures in patients with ESRD. Aim 2: To evaluate the effect of frequent vs. conventional hemodialysis on 12-month changes in endocrine function and whether these changes contribute to differential health-related outcomes. Aim 3: To evaluate the effect of frequent vs. conventional hemodialysis on 12-month changes in targeted hormones and factors related to mineral metabolism and inflammation, and whether these changes are associated with differences in left ventricular hypertrophy. PUBLIC HEALTH RELEVANCE: Project Narrative This is a proposed ancillary study to the Frequent Hemodialysis Network Trial of Daily vs. Conventional Hemodialysis. The major goals of this study are to characterize the endocrinopathies associated with ESRD, their change with dialysis frequency, and the relationship of these changes with health-related outcomes.