Lifestyle Intervention to Treat Erectile Dysfunction (LITE)

描述(由申请人提供)： 这项申请是为NIDDK多中心临床研究实施计划赠款(U34)计划的，以计划一项关于生活方式干预治疗患有勃起功能障碍(ED)的肥胖男性的疗效的临床试验。我们已经确定了2个临床中心和协调中心，以及一支在ED、生活方式干预、招募和保留大队列以及协调多中心试验方面的知名专家团队。U-34计划阶段将使我们能够完成为这次试验招募受试者所需的科学规划和行政活动。 勃起功能障碍的定义是持续无法达到和/或维持足够的勃起能力，这是一个重大的公共卫生问题，因为它在中年男性中普遍存在，与生活质量下降密切相关，最近被证实与内皮功能障碍有关，可能是心血管疾病(CVD)的先兆。最近的研究表明，生活方式干预(减肥和增加运动)可能提供一种有希望的新方法，既可以改善ED，又可以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对勃起功能障碍是否有效，并确定哪些男性最有可能对生活方式的改变做出反应。 我们提出了一项多中心随机对照试验，评估生活方式干预(减肥和体力活动)治疗患有ED的肥胖男性。这项名为生活方式干预治疗勃起功能(LITE)的项目将包括来自两个临床中心的300名患有勃起功能障碍的肥胖男性，他们将被随机分配到强化生活方式干预(基于最近几项NIDDK试验中成功使用的方案)或延迟治疗对照，并在随机化后6个月和12个月进行跟踪。主要目标是确定与对照条件相比，随机到强化的生活方式干预是否会导致ED的更大改善。我们还将比较生活方式干预和控制条件对勃起功能正常化、心脏代谢风险因素、下尿路症状(LUT)和12个月患者幸福感的影响，并确定适度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记物，以调查生活方式干预改善ED的机制。由于ED可能是CVD的先兆，生活方式干预可能特别重要，因为它们不仅可以作为ED的一线治疗，还可以预防或治疗CVD的多种表现，从而对个人和公共健康产生重大影响。

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.