Continuation of Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), Biostatistics Research Center

青少年减肥手术纵向评估的延续（Teen-LABS），生物统计学研究中心

• 批准号: 9754812
• 负责人: Todd M Jenkins
• 金额: $ 84.95万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-23 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9754812
• 关键词: Adolescent; Adverse event; Affect; Ancillary Study; Area; Behavioral; Benefits and Risks; Biometry; Body Weight decreased; Child; Clinical; Clinical Trials Data Monitoring Committees; Collection; Communication; Comorbidity; Data; Data Collection; Data Quality; Data Reporting; Databases; Effectiveness; Ensure; Funding; Future; Gastrectomy; Gastric Bypass; Goals; Grant; Health; Investigation; Lead; Leadership; Manuscripts; Measures; Methodology; Micronutrients; Monitor; Morbid Obesity; Obesity; Observational Study; Operations Research; Outcome; Pattern; Preparation; Procedures; Protocols documentation; Publications; Publishing; Quality Control; Quality of life; Request for Applications; Research; Research Design; Research Personnel; Resolution; Sample Size; Statistical Data Interpretation; Study Subject; System; Teenagers; Testing; Update; Validation; adverse outcome; bariatric surgery; bone health; cognitive function; cohort; data management; follow-up; meetings; obesity in children; operation; prospective; recruit; sound; treatment effect

Abstract This application requests renewal of the current grant supporting the Biostatistics Research Center (BRC) for the Teen-LABS (TL) consortium. This multicenter, prospective, observational study seeks to evaluate the risks and benefits of bariatric surgery in 242 consecutively recruited adolescents undergoing bariatric surgery at the participating five clinical centers. By the end of the current funding period (August 2016), most study subjects will have completed 5 years of follow-up. With a funding renewal, the BRC continue to lead the data collection and management and statistical analysis operations for the TL consortium. A renewal of funding will provide an opportunity to collect and examine long-term outcomes of Roux-en-Y gastric bypass and sleeve gastrectomy, the most commonly used operations today. Collection of additional longitudinal measures from years 6 to10 will importantly document durability of weight loss, comorbidity resolution, quality of life, micronutrient status, and will identify long-term adverse events. Continued collection of biospecimens will continue to drive new discovery by investigators utilizing the ancillary studies mechanism. Addition of new measures to study bone health, cognitive function, and behavioral patterns will further enhance the value of an extension of the study.

摘要 本申请要求更新支持生物统计学研究的现有资助 中心（BRC）为青少年实验室（TL）财团。这项多中心、前瞻性、观察性 一项研究旨在评估242名连续招募的减肥手术的风险和益处 在参与的五个临床中心接受减肥手术的青少年。年底前 到当前资助期（2016年8月），大多数研究对象将完成5年的 随访随着资金的更新，布拉迪斯拉发区域中心继续领导数据收集和管理工作， 和统计分析业务。资金的更新将提供一个 有机会收集和检查Roux-en-Y胃旁路术和袖状吻合术的长期结局 胃切除术是当今最常用的手术。收集额外的纵向 从第6年到第10年的测量将重要地记录减肥的持久性， 解决方案，生活质量，微量营养素状态，并将确定长期不良事件。 继续收集生物标本将继续推动研究人员利用 辅助学习机制。增加了研究骨骼健康、认知能力 功能和行为模式将进一步提高研究的延伸价值。