Sexual Dysfunction and Diabetes:Look AHEAD Sub-Study

描述（由申请人提供）：尽管糖尿病和性功能障碍之间的相关性是众所周知的，但在男性或女性糖尿病患者中，缺乏关于糖尿病诱导性功能障碍的病程的前瞻性对照数据。Look AHEAD是迄今为止美国国立卫生研究院资助的最大的研究之一，在美国16个临床中心有5,000名患者参与;这是一项关于减肥和锻炼与支持和教育组相比对广泛的生物医学和心理社会结果的影响的前瞻性调查。我们目前正在进行一项子研究（“向前看性功能障碍子研究”），该研究已获得资助（DK 60438），用于基线和第一年的数据收集。目前的建议是从第2年到第4年继续收集数据，届时所有参与者将接受全面的后续评估，包括心血管、血脂、运动和心理测量。我们建议在子研究（N=+650）中纳入额外的性类固醇激素血样和性功能自我报告评估。我们的招募率等于或高于我们的预期（见图1），并预期有足够的把握度来检验主要研究假设。性功能的变化将与性类固醇激素的变化以及其他心理社会结果（例如，抑郁评分）。子研究的数据将在五个研究中心（Miriam医院，田纳西大学，亚拉巴马大学，美国）收集。Penn，Johns霍普金斯）在Look AHEAD试验的第2年、第3年和第4年。参与者男女人数大致相等，其中约30%为少数民族。需要解决的具体问题是：㈠将在第4年评估性问题的发生率和风险关系，特别是性功能与其他健康特征（如基线体重指数、血红蛋白A1 c、健康水平）之间的关系。（ii）主要假设是，与对照组相比，在Look AHEAD体重减轻/特殊干预条件下的男性和女性患者将改善性功能。次要分析将检查性功能与BMI变化、健身水平、血糖控制改善以及与减肥干预相关的性激素变化之间的关系。(iii)最后，拟议的子研究将调查性功能变化与生活质量结果之间的关系。

DESCRIPTION (provided by applicant): Despite the well-known association between diabetes and sexual dysfunction, there is a lack of prospective, controlled data on the course of illness of diabetes-induced sexual dysfunction, in either male or female diabetics. Look AHEAD is one of the largest NIH-funded studies to date, with 5,000 patients at 16 clinical sites throughout the U.S.; it is a prospective investigation of the effects of weight loss and exercise, compared to a support and education group, on a broad set of biomedical and psychosocial outcomes. We are currently conducting a sub-study ("Look AHEAD Sexual Dysfunction Sub-Study"), which has been funded (DK 60438) for baseline and year I data collection. The current proposal is to continue data collection from years 2 to 4, at which time all participants will receive a comprehensive follow-up assessment, including cardiovascular, lipid, exercise and psychological measures. We propose to include additional blood samples for sex steroid hormones and a self-report assessment of sexual function to participants in the sub-study (N=+650). We have recruited at or above our projected rate (See Figure 1), and anticipate sufficient power to test the main study hypotheses. Changes in sexual function will be correlated with sex steroid hormone changes, as well as other psychosocial outcomes (e.g., depression scores). Data for the sub-study will be collected at five study sites (Miriam Hospital, Univ. Tennessee, Univ. Alabama, U. Penn, Johns Hopkins) during the 2nd, 3rd, and 4th years of the Look AHEAD trial. Participants are about equally divided between men and women, and include approximately 30% minority persons. Specific questions to be addressed are: (i) The prevalence and risk relationship of sexual problems will be evaluated through year 4, particularly the association between sexual functioning and other health characteristics (e.g. baseline BMI, hemoglobin A1c, fitness level). (ii)The principal hypothesis 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 relationships between sexual functioning and 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.