Sexual Dysfunction and Diabetes:Look AHEAD Sub-Study

描述（由申请人提供）：尽管众所周知糖尿病和性功能障碍之间存在关联，但在男性或女性糖尿病患者中，缺乏关于糖尿病诱发性功能障碍病程的前瞻性、对照数据。“展望”是迄今为止美国国立卫生研究院资助的最大研究之一，在美国16个临床地点有5000名患者；这是一项关于减肥和运动对广泛的生物医学和社会心理结果的影响的前瞻性调查，与支持和教育组相比。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随访评估，包括心血管、血脂、运动和心理测量。我们建议在子研究（N=+650）的参与者中纳入额外的性类固醇激素血液样本和性功能自我报告评估。我们的招募率达到或高于我们的预期（见图1），并预期有足够的能力来检验主要的研究假设。性功能的变化将与性类固醇激素的变化以及其他社会心理结果（如抑郁评分）相关。该子研究的数据将在Look AHEAD试验的第2年、第3年和第4年在5个研究地点（Miriam医院、田纳西大学、阿拉巴马大学、宾夕法尼亚大学、约翰霍普金斯大学）收集。参与者男女比例大致相等，其中约30%为少数民族。要解决的具体问题有：(i)将在四年级期间评估性问题的普遍性和风险关系，特别是性功能与其他健康特征（例如基线BMI、血红蛋白糖化血红蛋白、健康水平）之间的关系。（ii）主要假设是，在Look AHEAD减肥/特殊干预条件下，男性和女性患者的性功能比对照组有所改善。二级分析将检查性功能与体重指数、健康水平、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.