Clinical Research on Nonalcoholic Fatty Liver Disease

非酒精性脂肪肝的临床研究

• 批准号: 10450887
• 负责人: ROHIT LOOMBA
• 金额: $ 92.11万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10450887
• 关键词: Academic Medical Centers; Address; Adolescent; Adult; Affect; Ancillary Study; California; Cardiovascular system; Child; Childhood; Cirrhosis; Clinical; Clinical Course of Disease; Clinical Research; Clinical Trials; Contracts; Curcumin; Data Coordinating Center; Databases; Development; Diagnosis; Diagnostic; Disease; Disease Progression; Disease model; Enrollment; Environmental Risk Factor; Fibrosis; Funding; Future; Genetic; Hepatocyte; Heritability; Histologic; Histology; Image; Individual; Inflammation; Knowledge; Lead; Leadership; Life Style; Link; Liver; Lobular; Losartan; Malignant Neoplasms; Malignant neoplasm of liver; Measures; Medicine; Methods; Minority; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Nuclear Hormone Receptors; Oral; Outcome; Parents; Participant; Pathogenesis; Pediatrics; Performance; Phase; Phenotype; Placebos; Play; Predisposition; Prognosis; Proteomics; Publishing; Radiology Specialty; Randomized Clinical Trials; Reagent; Registries; Research; Research Personnel; Risk; Role; Safety; Serum Proteins; Site; Technology; Therapeutic Clinical Trial; Translational Research; United States; Universities; Validation; Variant; Work; aptamer; base; bioimaging; cell injury; chronic liver disease; clinical center; clinical data repository; clinical development; clinical material; cohort; design; diagnostic biomarker; disorder prevention; effective therapy; genetic variant; gut microbiome; imaging modality; improved; innovation; liver transplantation; longitudinal database; member; mortality; non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; noninvasive diagnosis; novel; predictive marker; prevent; public-private partnership; recruit; repository; translational study; treatment response; treatment strategy

Project Summary/Abstract The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) at Columbia University and its subcontracted sites at the University of California, San Diego have played a major role over the past 16 years in furthering the understanding of nonalcoholic fatty liver disease in children and adults. Given that NAFLD is the most common chronic liver disease in the United States and that known outcomes include cirrhosis, liver transplant and liver cancer, it is imperative that we develop better noninvasive measures to diagnose with more severe or progressive forms of NAFLD and that we find improved therapies with unique and rational targets. The proposal in this limited competition renewal for our Clinical Center demonstrates the progress made in longitudinal database studies and significant findings in past and current/ongoing randomized clinical trials in adults and children. Our Center and the Network describe plans for completion and continued development of clinical trials, for finding novel bio-imaging methods to assess response to therapy, to define and evaluate the performance of imaging as a noninvasive marker that might be used as a surrogate for certain features of NAFLD/NASH and as a means of tracking disease progression and to complete and develop ancillary studies for understanding the role of genetic and environmental factors in modulating the course of disease. In this regard, we lead studies in developing proteomic reagents as predictive and diagnostic markers for NAFLD; in elucidating the role of the gut microbiome, the role of nuclear hormone receptors, and the role of genetic variants in pediatric NAFLD. We intend to continue to play leading roles in the NASH CRN, as the PI is Co-Chair of the Steering Committee and Database Committee, a member of the Executive Committee, and Chair of the Pediatric Committee. Our Centers’ leading role in enrollment, along with our leadership in recruitment and retention of adults, children and minorities in the NASH CRN are expected to continue through completion of current trials and initiation of newly proposed studies.

项目概要/摘要 哥伦比亚大学非酒精性脂肪性肝炎临床研究网络 (NASH CRN) 及其在加州大学圣地亚哥分校的分包场地发挥了重要作用 过去 16 年里，我们致力于加深对儿童非酒精性脂肪肝的了解 和成人。鉴于 NAFLD 是美国最常见的慢性肝病 已知的后果包括肝硬化、肝移植和肝癌，我们必须 开发更好的非侵入性措施来诊断更严重或进行性的形式 NAFLD 并且我们找到了具有独特且合理目标的改进疗法。本次提案中 我们临床中心的有限竞争更新证明了纵向方面取得的进展 过去和当前/正在进行的随机临床试验的数据库研究和重要发现 成人和儿童。我们的中心和网络描述了完成计划并继续 开发临床试验，寻找新的生物成像方法来评估对 疗法，定义和评估成像作为无创标记物的性能 可以用作 NAFLD/NASH 某些特征的替代，并作为一种手段 跟踪疾病进展并完成和开展辅助研究以了解情况 遗传和环境因素在调节疾病过程中的作用。对此， 我们领导开发蛋白质组学试剂作为预测和诊断标记物的研究 非酒精性脂肪肝；阐明肠道微生物组的作用、核激素受体的作用以及 遗传变异在儿科 NAFLD 中的作用。我们打算继续在这方面发挥主导作用 NASH CRN，作为 PI 担任指导委员会和数据库委员会的联合主席、成员 执行委员会主席兼儿科委员会主席。我们中心的主导作用 入学率，以及我们在招募和保留成人、儿童和少数族裔方面的领导力 NASH CRN 预计将继续完成当前试验并启动 新提出的研究。