ESRD Endocrinopathy and Daily Dialysis

描述（由申请人提供）：摘要需要维持透析的终末期肾病（ESRD）影响了> 400，000名美国人，预计受影响的成年人数量将在未来几十年呈指数级增加。ESRD与各种内分泌和代谢异常、身体成分变化、尿毒症症状、生活质量和功能状态降低以及心血管和死亡风险升高相关。然而，透析频率和剂量的变化可以改变这些不良结局的程度尚不清楚。NIDDK申办的频繁血液透析网络（FHN）研究是一项随机试验，旨在评估频繁血液透析是否（每周6次）与常规（每周3次）血液透析超过12个月，导致心血管结构和功能、健康相关生活质量、身体功能、身体成分、认知功能、心理健康、营养状况、高血压、高磷酸盐血症和其他结果。我们建议通过在基线和随访期间对目标内分泌和代谢因素进行额外测量来补充FHN，以确定与ESRD相关的内分泌疾病是否与不良结局相关;透析频率是否改善了这些内分泌疾病;以及内分泌功能的变化是否与临床结局的变化相关。该研究将对与ESRD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局的关系产生新的见解。我们的三个具体目标是：在入组FHN研究的250例接受维持性血液透析的ESRD患者中：目的1：描述垂体和甲状腺相关激素和矿物质代谢异常的患病率和相关性，以及它们与ESRD患者生活质量、身体和认知功能、身体组成和心血管指标的相关性。目标二：评价频繁与常规血液透析对12个月内分泌功能变化的影响，以及这些变化是否导致不同的健康相关结局。目标3：评价频繁与常规血液透析对12个月靶向激素和矿物质代谢及炎症相关因子变化的影响，以及这些变化是否与左心室肥大差异相关。 公共卫生相关性： 项目叙述这是每日与常规血液透析频繁血液透析网络试验的拟定辅助研究。本研究的主要目的是描述与终末期肾病相关的内分泌疾病，其随透析频率的变化，以及这些变化与健康相关结局的关系。

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.