DHEA REPLACEMENT IN HEALTHY OLDER MEN AND WOMEN

健康老年男性和女性的 DHEA 替代

• 批准号: 6533877
• 负责人: DEBORAH L GOODMAN-GRUEN
• 金额: $ 74.8万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6533877
• 关键词: aging; body composition; bone density; bone metabolism; cardiovascular function; clinical research; clinical trials; cognition; dehydroepiandrosterone; emotions; hormone regulation /control mechanism; hormone therapy; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; immunity; insulinlike growth factor; interleukin 6; longitudinal human study; muscle strength; quality of life; sex behavior

DESCRIPTION: (adapted from Investigator's abstract) Levels of dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS), the major secretory product of the adrenal gland, decrease dramatically with age, concurrent with the onset of degenerative changes and chronic diseases associated with aging. Epidemiological evidence in humans and numerous animal studies have suggested that DHEA(S) has cardioprotective, antiobesity, antidiabetic, immuno-enhancing, and cancer-preventing properties. These observations have led to the proposal that restoration of DHEA levels in older adults to those of young adults may offer protection from age-associated health deficits. To date, clinical trials of DHEA replacement have been limited due to small sample size, lack of adequate power, restriction to one gender, failure to adjust for potential confounders (baseline endogenous hormone levels and age), lack of placebo comparison groups, and short duration of administration. This double blind, placebo-controlled randomized trial will determine the acceptability, benefits, and adverse effects of 50 mg daily oral DHEA replacements for one year in 100 men and 100 women, 55 to 85 years of age, who are healthy and not currently using any hormone therapy. Data will be collected at a screening visit, baseline visit, and at three follow-up visits over the course of one year. A wide range or biological outcomes will be studied including bone mineral density and metabolism, body composition and muscle strength, immune function, and cardiovascular risk factors. Central effects of DHEA will be investigated by assessing changes in mood and well-being, cognitive function, and sexuality. Cross-sectional and longitudinal analyses comparing the treatment and placebo groups on each health outcome will be adjusted for potentially confounding covariates such as smoking, alcohol consumption, exercise, diet, and supplements and the influence of gender, age and baseline endogenous DHEA level on each outcome variable will be examined. Potential mechanisms of DHEA action will be studied including biotransformation of DHEA to active steroids and steroid metabolites, enhancement of IGF-1 bioavailability, and inhibition of IL-6 production. In addition, potential adverse effects of DHEA administration will be systematically monitored.

描述：（根据研究者的摘要进行了改编） 脱氢表雄酮（DHEA）和DHEA-SULFATE（DHEAS），主要分泌 肾上腺的产物，随着年龄的增长而大大减少，与 与衰老相关的退行性变化和慢性疾病的发作。 人类和众多动物研究的流行病学证据表明 该DHEA具有心脏保护，抗肥胖，抗糖尿病，免疫增强， 和预防癌症的特性。这些观察结果导致了提案 老年人对年轻人的DHEA水平的恢复可能 提供免受与年龄相关的健康缺陷的保护。迄今为止，临床试验 由于样本量较小，缺乏DHEA替代的DHEA替代品受到限制 足够的权力，限制一个性别，未能调整潜力 混杂因素（基线内源激素水平和年龄），缺乏安慰剂 比较组和短期给药持续时间。这个双盲， 安慰剂控制的随机试验将确定可接受性，收益， 每天50毫克口服DHEA替代者一年100毫克的不利影响 男性和100个女性，55至85岁，健康，目前不健康 使用任何激素疗法。数据将在筛选访问中收集， 基准访问，并在一年的时间内进行了三次随访。一个 将研究包括骨矿物质的广泛范围或生物结局 密度和新陈代谢，身体成分和肌肉力量，免疫功能， 和心血管危险因素。 DHEA的主要效果将被研究 通过评估情绪和福祉，认知功能和性行为的变化。 比较治疗和安慰剂的横断面和纵向分析 每个健康结果的小组都将进行调整，以使可能混淆 吸烟，饮酒，运动，饮食和 补充剂和性别，年龄和基线内源性DHEA水平的影响 将检查每个结果变量。 DHEA动作的潜在机制 将研究包括DHEA对活性类固醇的生物转化和 类固醇代谢物，增强IGF-1生物利用度以及抑制 IL-6生产。此外，DHEA给药的潜在不利影响 将受到系统监控。