Testosterone Supplementation and Exercise in Elderly Men

老年男性的睾酮补充和锻炼

• 批准号: 7222252
• 负责人: Robert S Schwartz
• 金额: $ 21.42万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7222252
• 关键词: body composition; clinical research; clinical trials; disease /disorder onset; drug administration rate /duration; drug adverse effect; exercise; hormone therapy; human old age (65+); human subject; human therapy evaluation; mood disorders; patient oriented research; physical fitness; prostate disorder; sleep; testosterone

DESCRIPTION (provided by applicant): The long-term goal of this project is to better understand the physiological significance of the age related decline in serum testosterone (T) levels and the role of T supplementation, with and without exercise, in attenuating the reduced physical function and frailty found in aging men. Studies suggest that T replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory and behavior, but the risks of chronic treatment, especially on the prostate, heart and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation yet mitigate the possible side effects has not been studied in older men. A randomized, double-blinded, placebo-controlled study (complete, balanced, 2-way factorial design) will be performed. The factors are testosterone dose (placebo, low-dose [25 mg/d], usual-dose [50 mg/d]) crossed with progressive resistance training (some versus none). This study will determine: 1) the beneficial (body composition, physical performance, and functional performance) and adverse (erythrocytosis, and prostate growth) effects of low-dose versus usual replacement-dose T therapy (as T gel; AndroGelmM), in healthy older men with low normal to slightly low serum T levels; and 2) the possible positive interaction between low-dose T supplementation and progressive resistance training to further enhance anabolic and functional effects while reducing side effects. These studies will provide important new information regarding the risk/benefit profile of low-dose T supplementation compared to conventional T replacement doses. These studies will also influence future development of androgen formulations and guide intervention trials to assess the benefits and risks of T treatment, in both healthy and frail elderly men, to prevent frailty and help restore function.

描述（由申请人提供）：该项目的长期目标是更好地了解血清睾丸激素水平（T）水平与年龄相关的生理意义以及补充T的作用，无论有没有运动，在衰老男性中发现了降低的身体功能和脆弱性。研究表明，健康老年男性的T替代对身体成分，肌肉，骨骼，记忆和行为具有有益的影响，但是慢性治疗的风险，尤其是对前列腺，心脏和睡眠质量的风险，并不完全清楚。因此，最希望将老年男性的“有效”范围补充为最低的“有效”范围。但是，尚未对较低的替代剂量的效果进行很好的研究。此外，在老年男性中尚未研究锻炼可能增强T的积极影响但减轻可能的副作用的重要相互作用。将进行一项随机，双盲，安慰剂对照研究（完整，平衡，2向阶乘设计）。这些因素是睾丸激素剂量（安慰剂，低剂量[25 mg/d]，通常的剂量[50 mg/d]），并进行了进行性耐药性训练（有些对无）。这项研究将确定：1）低剂量与通常的替代剂量T疗法（作为T Gel; Androgelmm）的有益（身体成分，身体性能和功能性能）和不良（红细胞增多和前列腺生长）的影响，在健康的老年男性中，患有低正常至正常血清T水平； 2）低剂量T补充和进行性耐药性训练之间可能存在正相互作用，以进一步增强合成代谢和功能效应，同时减少副作用。这些研究将提供有关与常规T替代剂量相比，补充低剂量T的风险/收益概况的重要新信息。这些研究还将影响雄激素配方的未来发展，并指导干预试验，以评估健康和虚弱的老年男性中T治疗的益处和风险，以防止脆弱并帮助恢复功能。