Sexual Dysfunction: Effects of Weight-Loss

描述(由申请人提供)： 性功能障碍是非常普遍的，也是痛苦的常见来源。 尽管糖尿病和性行为之间的联系已经得到了充分的证明 功能障碍、性功能不全的数据将在主要前瞻收集 审判。因此，当前的应用程序旨在提供辅助数据 600人(男300人，女300人)性功能和激素功能 主要试验的参与者。大约125名受试者将在 5个地点中的每个(米里亚姆医院、圣卢克斯-罗斯福、 阿拉巴马州、宾夕法尼亚大学和约翰霍普金斯大学)期间 审判的头两年。讨论了三个关键的研究问题： (1)性问题在男性和女性中的流行和分布 前瞻性试验中的糖尿病患者将在基线上进行评估，特别是 性功能与儿童其他健康特征之间的关系 样本(例如，基线体重指数、血红蛋白、健康水平)。荷尔蒙水平 基线值也同样与性功能有关。(Ii)主事人 这项拟议研究的假设是，男性和女性患者看起来 提前减肥/特殊干预条件将改善性生活 功能与控件进行比较。二次分析将考察对 性功能BMI的变化，健康水平，血糖控制的改善， 以及与减肥干预相关的性激素变化。(Iii) 最后，拟议的分项研究将调查 性功能和生活质量结果的变化。这是假设的 性功能改善的糖尿病患者将有显著的 情绪状态和整体生活质量的改善。这些加在一起， 分析将提供有关性行为流行率和分布的独特数据 以及糖尿病男性和女性的荷尔蒙问题，这些因素之间的联系 对其他人口和健康特征的问题，以及 特殊干预条件对性功能和激素功能的影响 病人。此外，拟议的研究将提供关于 性功能结局与其他关键心境指标的关系 状态和生活质量主要以前瞻性试验为主。

DESCRIPTION (provided by applicant): Sexual dysfunction is highly prevalent and a frequent source of distress. Despite the well-documented association between diabetes and sexual dysfunction, no sexual function data will be collected in the main Look AHEAD trial. Accordingly, the current application aims to provide ancillary data regarding sexual and hormonal function in 600 (300 male, 300 female) participants in the main trial. Approximately 125 subjects will be recruited at each of 5 sites (Miriam Hospital, St. Lukes-Roosevelt, the University of Alabama, the University of Pennsylvania, and Johns Hopkins University) during the first two years of the trial. Three key research questions are addressed: (i) The prevalence and distribution of sexual problems among male and female diabetics in the Look AHEAD trial will be evaluated at baseline, particularly the association between sexual functioning and other health characteristics of the sample (e.g. baseline BMI, hemoglobin A lc, fitness level). Hormonal levels at baseline will similarly be related to sexual function. (ii) The principal hypothesis for the proposed study is that male and female patients in the Look AHEAD weight loss/special intervention condition will have improved sexual function compared to controls. Secondary analyses will examine the effects on sexual functioning of changes in BMI, fitness level, improved glycemic control, and sex hormone alterations associated with the weight loss intervention. (iii) Finally, the proposed sub-study will investigate the relationship between changes in sexual function and quality of life outcomes. It is hypothesized that diabetic patients with improved sexual function will have significant improvements in mood state and overall quality of life. Taken together, these analyses will provide unique data on the prevalence and distribution of sexual and hormonal problems in diabetic men and women, the association of these problems to other demographic and health characteristics, and the effects of the special intervention condition on sexual and hormonal function in these patients. Additionally, the proposed study will provide data on the relationship between sexual function outcomes and other key measures of mood state and quality of life in the main Look AHEAD trial.