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代谢中的重要问题。LABS探索患者特征，临床状况，血清学和遗传标记，以及临床，心理社会和卫生经济结果之间的关系。LABS的主要成就是建立了一个研究联盟及其基础设施;定义了探索领域，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;确定适当的指标;设计和实施基于网络的数据收集系统和广泛的数据库;完成了一个超过5000名参与者的队列，以研究减肥手术的短期安全性;招募2000多人进入一个人群队列，旨在作为长期随访的重点，以解决减肥手术的安全性和有效性;并实施2项子研究，分别关注糖尿病解决机制和比整个队列更深入的精神病学和生活质量数据。在拟议的LABS延续期间，我们将在6个临床中心的9个临床研究中心建立严格的研究基础设施，LABS研究者将解决具有科学意义的研究方案，并制定了包括30天结局的研究方案。（安全性，LABS-1）研究约5,000名参与者和一个较小的队列2，400名参与者对减肥手术的纵向影响进行详细研究。LABS-3糖尿病是胃旁路术患者体重减轻机制和对2型糖尿病影响的子研究。该提案是OHSU对NIDDK发布的有限竞争RFA的回应，该RFA征求目前参与LABS联盟的研究者的合作协议申请，以研究减肥手术及其在理解肥胖及其并发症方面的作用，为期五年。LABS的扩展将评价手术的新兴效应和随时间变化的效应。 在美国，超过5%的成年人符合减肥手术的体重标准，但每年只有不到2%的合格患者接受这种治疗。有必要进行研究来确定受益和风险，以告知有关在符合条件的患者中应进行减肥手术的程度的问题。

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.