RESTORATION OF PLASMA GH LEVELS WITH RHGRF IN OLDER ADULTS

这项研究的具体目的是恢复血浆生长激素水平，这往往是缺乏正常老年志愿者和充血性心力衰竭患者，在年轻人中发现的水平。 剂量、频率和持续时间研究。 随着年龄的增长，循环GH水平下降，伴有临床显著的后遗症。 另一种在老年人中也与功能下降相关的普遍病症是充血性心力衰竭（CHF）。 血浆GH水平的恢复已被证明可改善正常老年人（骨矿物质密度增加和身体成分变化）和CHF患者（心肌功能改善）的功能。用GH替代会导致不可接受的不良副作用，而重组人生长激素释放因子可以完全避免这些副作用。然而，最佳剂量和给药方式尚未确定。 通过低IGF-1水平评估，将确定GH水平降低的老年人。 他们将接受rhGRF静脉推注，然后随机分为每天一次或每天两次皮下（皮下）rhGRF给药21天。 诊断为CHF（纽约心脏协会II和III级）的老年个体也将经历与正常老年志愿者相同的方案。将老年人的所有反应与正常年轻志愿者的反应进行比较。 年轻志愿者将不会接受21天的治疗。本研究的终点是评价老年志愿者接受rhGRF治疗21天后的GH反应以及对单次IV或s.c.在年轻志愿者中施用rhGRF。 希望本研究将确定正常老年人和老年CHF患者GH水平恢复至年轻人水平所需的最小剂量和频率。

The specific aim of this study is to restore plasma growth hormone levels, which are often deficient in normal elderly volunteers and patients with congestive heart failure, to the levels found in younger adults. A dose, frequency and duration study. There is a decline in circulating GH levels with advancing age, which is accompanied by clinically significant sequelae. Another prevalent condition in the elderly also associated with decline in function is cogestive heart failure (CHF). Restoration of plasma GH levels has been shown to result in improved function both in the normal elderly (increaed bone mineral density and changes in body composition) and in patients with CHF (improved myocardial function). Replacement with GH results in unacceptable untoward side effects which can be entirely avoided with recombinant human growth hormone releasing factor. However, the optimal dose and mode of administration have not been established. Elderly individuals with a decrease in GH levels, as assessed by low IGF-1 levels, will be identified. They will receive an IV bolus infusion of rhGRF and then randomized into a daily or twice daily subcutaneous (s.c.) administration of rhGRF for 21 days. Elderly individuals with a diagnosis of CHF (New York Heart Association class II & III) will also undergo the same protocol as the normal elderly volunteers. All responses in the elderly will be compared to that of normal young volunteers. Young volunteers will not undergo the 21 days of treatment. The end point of this study is the evaluation of GH response following 21 days of rhGRF treatment in the old volunteers and GH response to the single IV or s.c. administration of rhGRF in young volunteers. It is hoped that this study will establish the minimal dose and frequency required to restore GH levels, in the normal elderly and elderly patients with CHF to those found in young individuals.