IGF-1 GENERATION TEST IN CHILDREN WITH CHRONIC KIDNEY FAILURE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的主要目的是开发标准化的IGF-I代测试，可用作慢性肾脏疾病儿童生长激素不敏感的标志。用于检测CKD儿童生长激素反应性的主要结果变量将是对外源性生长激素(Nutroin AQ)的反应产生的刺激IGF-I水平。所有受试者将分别接受每天0.025毫克/公斤和每天0.05毫克/公斤剂量的生长激素，每次为期七天。一半的受试者将被随机分配，先接受0.025毫克/公斤/天的剂量，然后再接受0.05毫克/公斤/天的剂量。另一半受试者将被随机分配，先接受0.05毫克/公斤/天的剂量，然后再接受0.025毫克/公斤/天的剂量。在两个剂量水平的治疗期间，将在治疗的第1、5和8天测量所有受试者的IGF-I浓度。预计这些IGF-I水平将与年化身高速度呈正相关。6个月时身高年化速度为5.7厘米的受试者将在治疗的最初一周接受额外的IGF生成测试，剂量为0.1 mg/kg/天。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this research study is to develop a standardized IGF-I generation test that can be used as a marker for growth hormone insensitivity in children with chronic kidney disease. The primary outcome variable that will be used to examine growth hormone responsiveness in children with CKD will be the stimulated IGF-I levels generated in response to exogenous growth hormone (Nutropin AQ). All subjects will receive both the 0.025 mg/kg/day and 0.05 mg/kg/day doses of growth hormone for seven days each. Half of the subjects will be randomized to receive the 0.025 mg/kg/day dose first followed by the 0.05 mg/kg/day dose, and the other half of subjects will be randomized to receive the 0.05 mg/kg/day dose first followed by the 0.025 mg/kg/day dose. IGF-I concentrations will be measured in all subjects on Days 1, 5 and 8 during the treatment with each of the two dose levels. It is anticipated that these IGF-I levels will positively correlate to annualized height velocity. Subjects with an annualized height velocity < 5.7 cm at Month 6 will undergo an additional IGF generation test on Days 1, 5 and 8 during the initial week of treatment with a higher dose of 0.1 mg/kg/day.