Bariatric Surgery Clinical Research Consortium

描述(由申请人提供)： 减肥手术纵向评估(LABS)联盟成立于2003年，旨在解决肥胖和病态肥胖者减肥手术和新陈代谢方面的重要问题。实验室探索患者特征、临床条件、血清学和遗传标记以及临床、心理社会和健康经济结果之间的关系。实验室的主要成就是建立了一个研究联盟及其基础设施；确定了探索的领域、具体的研究问题和有效的研究设计，以有效地解决这些问题；确定了适当的衡量标准；设计和实施了一个基于网络的数据收集系统和一个广泛的数据库；完成了5000多名参与者的队列，以研究减肥手术的短期安全性；招募了2000多人加入一个旨在成为长期后续重点的人队列，以解决减肥手术的安全性和有效性；并实施2项子研究，分别侧重于糖尿病解决的机制和比全队列中更深入的精神病学和生活质量数据。在这次拟议的实验室续展期间，我们将在6个临床中心的9个临床站点的严格研究基础上建立基础设施，研究人员将解决具有科学重要性的研究方案，制定和建立包括约5,000名参与者的30天结果(安全性，LABS-1)研究和2,400名参与者的较小队列，以对减肥手术的纵向影响进行详细研究。LABS-3糖尿病是胃旁路手术患者体重减轻机制和对2型糖尿病影响的子研究。这项提案是OHSU对NIDDK发布的有限竞争RFA的回应，NIDDK正在征求目前参与实验室联盟的研究人员的合作协议申请，以研究减肥手术及其在了解肥胖及其并发症方面的作用，为期五年。延长实验室将评估手术的新效果和随着时间的推移而发生变化的效果。 在美国，超过5%的成年人符合减肥手术的体重标准，但每年接受这种疗法的合格患者不到2%。有必要进行研究，以确定益处和风险，以告知有关符合条件的患者应在多大程度上进行减肥手术的问题。

DESCRIPTION (provided by applicant): Longitudinal Assessment of Bariatric Surgery (LABS) consortium was established in 2003 and was conceived to address important issues in bariatric surgery and metabolism in the obese and morbidly obese. LABS explores relationships of patient characteristics, clinical conditions, serologic and genetic markers, and clinical, psychosocial and health economic outcomes. The primary achievements of LABS have been to establish a research consortium and its infrastructure; define the domains of exploration, specific research questions and an effective study design to efficiently address those questions; identify appropriate metrics; design and implement a web-based data collection system and an extensive database; complete a cohort of over 5000 participants to study the short-term safety of bariatric surgery; enroll over 2000 people into a person cohort intended to be the focus of longer-term follow-up to address safety and efficacy of bariatric surgery; and implement 2 sub studies focusing on the mechanisms of diabetes resolution and more in-depth psychiatric and quality of life data, respectively, than in the full cohort. During this proposed continuation of LABS we will build on the rigorous research infrastructure across 9 clinical sites at the 6 Clinical Centers LABS investigators will address scientifically important Research protocols were developed and instituted to include a 30 day outcomes (safety, LABS-1) study of approximately 5,000 participants and a smaller cohort of 2,400 participants to conduct a detailed study of the longitudinal effects of bariatric surgery. LABS-3 diabetes is a sub-study of mechanisms of weight loss and impact on type 2 diabetes in gastric bypass patients. This proposal is the OHSU response to the limited competition RFA issued by the NIDDK soliciting cooperative agreement applications from investigators currently participating in the LABS consortium to study bariatric surgery and its role in the understanding of obesity and its complications for an additional five years. An extension to LABS will evaluate emerging effects of surgery and effects that change overtime. More than 5% of adults in the US meet the weight criteria for bariatric surgery but less that 2% of the eligible patients undergo this therapy per year. Research to define the benefits and risks is necessary to inform the question regarding the extent to which bariatric surgery should be done in eligible patients.