Intra-Subject Hormone Variation

受试者体内激素变化

• 批准号: 6888907
• 负责人: Donald Brambilla
• 金额: $ 92.71万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6888907
• 关键词: aging; androgen binding protein; androstenedione; clinical research; cortisol; dehydroepiandrosterone; endocrinology; enzyme linked immunosorbent assay; estrone; hormone regulation /control mechanism; hormone therapy; human subject; hypogonadism; longitudinal human study; luteinizing hormone; male; male reproductive system; prolactin; radioimmunoassay; testosterone

DESCRIPTION: (provided by applicant) The dearth of reliable data to permit estimation of intra-subject variability in male hormones over time (both short and longer-term) is a glaring deficiency in the field of male reproductive endocrinology. Data from our Massachusetts Male Aging Study (MMAS) suggests that hypogonadism may not be a stable syndrome over time. Moreover, data on intra-subject variability is essential to the design of any scientifically credible trial of androgen replacement in men. These data are also important at the level of patient care- especially the adequacy of a single early morning serum sample for diagnostic purposes. This study has three primary aims: (1) To obtain reliable estimates of short term (day-to-day) and longer-term (six months) intra-subject variation in hormone levels in adult men. While the main focus is on testosterone (total, free, bioavailable and the free androgen index), other major hormones (DHT, SHBG, LH, prolactin, DHEA, DHEAS, cortisol, androstenedione, androstanediol glucoronide (3-alpha-diol G) and estrone) are included because of rapidly growing interest in their actions, and because it's cost-efficient also to gather these data in a single study; (2) To determine if the intra-subject variation in hormone levels changes with age (a few studies have focused on relatively young men); (3)To examine the magnitude of any seasonal variability (this could affect clinical interpretation of results and power calculations in clinical trials). It is also important to estimate the relative contribution of assay variation and biological variation to total intra-subject variation. The proposed research builds on nearly 20 years of work on the MMAS and results will have an impact at several levels- the epidemiology of male endocrine change, clinical trials design and the clinical management of individual patients with androgen deficiency.

描述：（由申请人提供）缺乏可靠的数据来估计男性激素随时间（短期和长期）的受试者内部变异性，这是男性生殖内分泌学领域的一个明显缺陷。我们马萨诸塞州男性衰老研究（MMAS）的数据表明性腺功能减退可能不是一个稳定的综合征。此外，受试者内部变异的数据对于设计任何科学可信的男性雄激素替代试验至关重要。这些数据在患者护理水平上也很重要，特别是用于诊断目的的单一清晨血清样本的充分性。