INDICES FOR DETERMINING SOMATOTROPIN DEFICIENCY IN ADULTS

确定成人生长激素缺乏的指数

• 批准号: 6305361
• 负责人: BAHA M ARAFAH
• 金额: $ 1.92万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6305361
• 关键词: clinical research; diagnosis design /evaluation; diagnostic tests; endocrine disorder; human subject; somatotropin

Evaluation of growth hormone or somatotropin secretary capacity in adults is difficult and the interpretation of clinical testing results for somatotropin sufficiency has historically been a controversial area in endocrinology. 1) The primary objective of this study is to compare a set of diagnostic tests commonly used to identify patients with somatotropin deficiency and determine the relative utility of each test for diagnostic use in somatotropin-deficient adult populations. Using the null hypothesis, we expect to find no difference between the tests in ability to discriminate clinically diagnosed somatotropin-deficient individuals from healthy control subjects when matched for age, gender, ethnic origin, and body mass index. 2) The secondary objective of this study is to evaluate the value of these stimulation tests as well as that of plasma IGF-I levels in a sub-population of patients who have a high potential for somatotropin deficiency. 3) A third objective of the study is to evaluate the safety of each test by determining and recording the frequency and severity of adverse events associated with each test. This will be a multi-center study of cross-sectional design, involving 100 patients. Approximately 20 to 25 patients will be studied at our institution. Three patients' populations will be represented in this study. The somatotropin-deficient (diseased) population will be represented by approximately 40 patients who have been diagnosed to have adult-onset hypopituitarism with multiple hormone deficiencies (two or more previously identified hormone deficiencies). Because multiple hormone deficiency strongly suggests the presence of somatotropin deficiency, the clinical diagnosis of adult-onset hypopituitarism combined with multiple hormone deficiency will serve as the primary focus of this study. The control population will be represented by approximately 40 healthy volunteers between 18 and 70 years of age. Volunteer selection will be matched so that the group composition resembles that of the multiple hormone- deficient experimental group for the following variables: age, gender, ethnic origin, and body mass index (BMI). A third group will include approximately 20 patients who have been clinically diagnosed as having organic pituitary disease and either one or no known hormonal deficiencies. The diagnostic utility of five somatotropin stimulation tests and one somatotropin-dependent biochemicla marker, (IGF-1) will be evaluated. Each test will be judged according to its agreement with the clinical diagnosis of the patient (either somatotropin deficient or normal). Stimulation tests include the following: Arginine; 1-dopa; arginine/ 1-dopa; arginine/growth hormone-releasing hormone (GHRH) and insulin tolerance test (ITT). The order of stimulation test administration will be determined by a pre-written randomized table listing a specific test sequence for each patient number.

评估成人生长激素或生长激素的分泌能力很困难，并且生长激素充足性的临床检测结果的解释历来是内分泌学中的一个有争议的领域。 1) 本研究的主要目的是比较一组常用于识别生长激素缺乏症患者的诊断测试，并确定每种测试在生长激素缺乏成年人群中诊断用途的相对效用。 使用零假设，当年龄、性别、种族血统和体重指数匹配时，我们期望发现这些测试在区分临床诊断的生长激素缺乏个体与健康对照受试者的能力方面没有差异。 2) 本研究的次要目的是评估这些刺激试验的价值以及血浆 IGF-I 水平在生长激素缺乏可能性较高的患者亚群中的价值。 3) 该研究的第三个目标是通过确定和记录与每次测试相关的不良事件的频率和严重程度来评估每次测试的安全性。这将是一项多中心横断面设计研究，涉及 100 名患者。 我们机构将研究大约 20 至 25 名患者。 本研究将代表三个患者群体。生长激素缺乏（患病）人群将由大约 40 名已被诊断为成人发病的垂体机能减退症并伴有多种激素缺乏（先前发现的两种或多种激素缺乏）的患者代表。 由于多种激素缺乏强烈提示存在生长激素缺乏，因此成人发病的垂体功能减退症合并多种激素缺乏的临床诊断将成为本研究的主要重点。 对照人群将由大约 40 名年龄在 18 岁至 70 岁之间的健康志愿者组成。 志愿者的选择将进行匹配，以便在以下变量方面，该组的组成类似于多种激素缺乏实验组的组成：年龄、性别、种族血统和体重指数（BMI）。 第三组将包括约 20 名经临床诊断患有器质性垂体疾病且患有一种或不患有已知激素缺乏症的患者。将评估五种生长激素刺激试验和一种生长激素依赖性生化标记物 (IGF-1) 的诊断效用。每次测试将根据其与患者临床诊断（生长激素缺乏或正常）的一致性进行判断。刺激测试包括以下内容： 精氨酸； 1-多巴；精氨酸/1-多巴；精氨酸/生长激素释放激素（GHRH）和胰岛素耐量试验（ITT）。 刺激测试的实施顺序将由预先编写的随机表确定，该表列出了每个患者编号的特定测试序列。