IGF-1 GENERATION TEST IN CHILDREN WITH CHRONIC KIDNEY FAILURE

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究的主要目的是开发一种标准化的IGF-I生成试验，可用作慢性肾病儿童生长激素不敏感性的标志物。用于检查CKD儿童生长激素反应性的主要结局变量是外源性生长激素（Nutropin AQ）刺激产生的IGF-I水平。所有受试者将接受0.025 mg/kg/天和0.05 mg/kg/天剂量的生长激素，各持续7天。一半受试者将随机接受0.025 mg/kg/天剂量，随后接受0.05 mg/kg/天剂量，另一半受试者将随机接受0.05 mg/kg/天剂量，随后接受0.025 mg/kg/天剂量。在两个剂量水平治疗期间的第1、5和8天，测量所有受试者的IGF-I浓度。预计这些IGF-I水平将与年化身高增长速度呈正相关。第6个月时年化身高增速< 5.7 cm的受试者将在治疗的第1周、第5天和第8天接受额外的IGF生成试验，剂量较高，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.