Lifestyle Intervention to Treat Erectile Dysfunction (LITE)

描述（由申请人提供）： 本申请是NIDDK多中心临床研究实施计划补助金（U34），计划进行一项关于生活方式干预治疗肥胖男性勃起功能障碍（艾德）疗效的临床试验。我们已经确定了2个临床中心和协调中心，以及一个由艾德、生活方式干预、招募和保留大型队列和协调多中心试验方面的成熟专家组成的团队。U-34计划阶段将使我们能够完成准备招募本试验受试者所需的科学计划和管理活动。 艾德，定义为持续无法达到和/或维持足以进行性行为的勃起，是一个重要的公共卫生问题，因为它在中年男性中流行，与生活质量下降密切相关，最近建立了与内皮功能障碍的联系，并可能作为心血管疾病（CVD）的先兆。最近的研究表明，生活方式干预（减肥和增加活动）可能提供一种有前途的新方法，可以改善艾德以及降低心血管疾病的风险。需要一项明确的随机试验来确定生活方式干预是否对艾德有效，并确定那些最有可能对生活方式改变做出反应的男性。 我们提出了一个多中心随机对照试验评估生活方式干预（减肥和身体活动）治疗肥胖男性ED。这个项目，题为生活方式干预治疗勃起功能（LITE），将包括来自两个临床中心的300名患有艾德的肥胖男性，他们将被随机分配到一个强化的生活方式干预组（基于最近几项NIDDK试验中成功使用的方案）或延迟治疗控制，并在随机化后6个月和12个月进行随访。主要目的是确定与对照组相比，随机分配到强化生活方式干预组是否会导致艾德更大的改善。我们还将比较生活方式干预和控制条件对艾德正常化、心脏代谢危险因素、下尿路症状（LUTS）和患者12个月时的健康状况的影响，并确定缓解治疗效果的基线特征，潜在地确定最有可能经历勃起功能改善或正常化的男性。将采集血液样本以评估氧化损伤、内皮功能和炎症的生物标志物，以研究生活方式干预改善艾德的机制。由于艾德可能是心血管疾病的先兆，生活方式干预可能特别重要，因为它们不仅可以用作艾德的一线治疗，而且可以预防或治疗心血管疾病的许多表现，因此对个人和公共健康有重大影响。

DESCRIPTION (provided by applicant): This application is for an NIDDK Multi-Center Clinical Study Implementation Planning Grant (U34) to plan a clinical trial on the efficacy of lifestyle intervention to treat obese men with erectile dysfunction (ED). We have identified the 2 clinical centers and coordinating center and a team of well-established experts in ED, lifestyle intervention, recruitment and retention of large cohorts and coordinating multi-center trials. The U-34 planning phase will allow us to complete the scientific planning and administrative activities that are required to prepare to recruit subjects for this trial. ED, defined as the consistent inability to achieve and/or maintain an erection sufficient for sexual performance, is a significant public health concern because of its prevalence among middle aged men, its strong association with diminished quality of life, and its recently-established link to endothelial dysfunction and likely role as a harbinger of cardiovascular disease (CVD). Recent studies suggest that that lifestyle intervention (weight loss and increased activity) may offer a promising new approach that could improve ED as well as reducing CVD risk. A definitive randomized trial is needed to determine whether lifestyle intervention is effective for ED and to identify those men who are most likely to respond to lifestyle change. We propose a multi-center randomized controlled trial evaluating lifestyle intervention (weight loss and physical activity) to treat obese men with ED. This project, entitled Lifestyle Intervention to Treat Erectile Function (LITE), will include 300 obese men with ED from two clinical centers who will be randomly assigned to an intensive lifestyle intervention (based on protocols used successfully in several recent NIDDK trials) or delayed treatment control and followed at 6 and 12 months post-randomization. The primary goal is to determine whether randomization to an intensive lifestyle intervention results in greater improvement in ED compared to the control condition. We will also compare the lifestyle intervention and control conditions on normalization of ED, cardio-metabolic risk factors, lower urinary tract symptoms (LUTS), and patient well-being at 12-months and identify baseline characteristics that moderate the effect of treatment, potentially identifying men most likely to experience improved or normalized erectile function. Blood samples will be collected to assess biomarkers of oxidative damage, endothelial function and inflammation to investigate the mechanisms by which lifestyle intervention improves ED . Since ED may be a harbinger of CVD, lifestyle interventions may be of particular importance because they may not only be used as a first-line treatment for ED, but also may prevent or treat the many manifestations of CVD and thus would have a significant impact on personal and public health.