Clinical Research on Nonalcoholic Fatty Liver Disease

非酒精性脂肪肝的临床研究

• 批准号: 8520284
• 负责人: JOEL Edward LAVINE
• 金额: $ 77.69万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520284
• 关键词: Address; Adult; Affect; Age; American; Ancillary Study; Area; Attention; Biological Markers; Biopsy; Body mass index; Burn injury; California; Candidate Disease Gene; Cardiovascular Diseases; Cardiovascular system; Child; Childhood; Cicatrix; Cirrhosis; Clinical; Clinical Research; Clinical Trials; Collection; Comorbidity; Control Groups; Controlled Clinical Trials; Data; Data Coordinating Center; Databases; Development; Diabetes Mellitus; Diagnosis; Diet; Disease; Disease Progression; Double-Blind Method; Dyslipidemias; Elements; Enrollment; Ethnic Origin; Evaluation; Fatty Liver; Fatty acid glycerol esters; Feasibility Studies; Funding; Gender; Genetic; Genetic Markers; Goals; Grant; Hepatic; Hispanics; Histology; Histopathology; Hypertension; Image; Inflammation; Knowledge; Length; Life Style; Liver; Liver diseases; Longitudinal Studies; Metformin; Methods; Modification; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Non-Insulin-Dependent Diabetes Mellitus; North America; Obesity; Parents; Pathogenesis; Patients; Performance; Phenotype; Pilot Projects; Pioglitazone; Placebo Control; Placebos; Population; Population Control; Prevention; Proteomics; Publications; Quality of life; Race; Randomized; Randomized Clinical Trials; Reporting; Research; Research Personnel; Risk; Risk Factors; Role; Safety; Sampling; Serum; Specificity; Staging; Systems Biology; Therapeutic; Therapeutic Studies; Therapy Clinical Trials; Tissue Sample; United States Dept. of Health and Human Services; United States National Institutes of Health; Universities; Vitamin E; Work; base; cardiovascular disorder risk; chronic liver disease; clinical material; cohort; disease natural history; effective therapy; ethnic minority population; follow-up; girls; liver biopsy; meetings; metabolomics; non-alcoholic fatty liver; non-diabetic; nonalcoholic steatohepatitis; prospective; public health relevance; sobriety; tool

DESCRIPTION (provided by applicant): Investigators at the University of California, San Diego propose their continued inclusion as a Clinical Center within the "Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)". NASH is the most prevalent liver disease in children and one of the most common causes of chronic liver disease in adults. NASH is associated with cardiovascular disease risk factors such as type 2 diabetes, hypertension, dyslipidemia and obesity. The Network's broad, long-term objectives are to advance understanding of the pathogenesis, natural history, genetics, histopathology and treatment for NASH. The NASH CRN currently is conducting 2 multi-center, double-blind, randomized, placebo-controlled clinical trials which require completion in the renewal period, one In children 8-17 years inclusive and the other in adults 18 years and over. The pediatric study called "TONIC", has 173 subjects enrolled for a 2-year treatment, assessing safety and efficacy of metformin or Vitamin E versus placebo. The adult study called "PIVENS", has 247 subjects enrolled for 2-years of treatment to assess pioglitazone or Vitamin E versus placebo. Additionally, there is a genetics study called "GOALS", which requires many more children and their parents to enroll in order to identify candidate genes associated with NASH, and an ongoing Database study with 1262 current subjects intended to assess the natural history of NASH. The Database also will be invaluable for evaluating life-style factors in NASH and evaluating noninvasive biomarkers and imaging for diagnosis and progression. In this renewal we aim to expand the database with under-represented and important biopsy-proven sub-populations such as children (particularly girls), Hispanics, blacks and those with cirrhosis to better understand the role of age, gender, ethnicity, race, genetics and lifestyle in the development of NASH and Its co-morbidities. We aim to Identify appropriately matched control populations without NAFLD to permit comparisons to those with NAFLD. We propose the conduct of another randomized placebo-controlled clinical trial to assess other treatment options for children with NASH, and we will complete, analyze and report on the treatment studies from the last grant period now coming to fruition.

描述（由申请人提供）： 加州大学圣地亚哥分校的研究人员建议继续将其作为临床中心纳入“非酒精性脂肪性肝炎临床研究网络 (NASH CRN)”。 NASH 是儿童中最常见的肝病，也是成人慢性肝病的最常见原因之一。 NASH 与 2 型糖尿病、高血压、血脂异常和肥胖等心血管疾病危险因素有关。该网络的广泛、长期目标是增进对 NASH 发病机制、自然史、遗传学、组织病理学和治疗的了解。 NASH CRN 目前正在进行 2 项多中心、双盲、随机、安慰剂对照临床试验，需要在更新期内完成，其中一项针对 8-17 岁儿童，另一项针对 18 岁及以上成人。这项名为“TONIC”的儿科研究招募了 173 名受试者，接受为期 2 年的治疗，评估二甲双胍或维生素 E 与安慰剂的安全性和有效性。这项名为“PIVENS”的成人研究招募了 247 名受试者，接受为期 2 年的治疗，以评估吡格列酮或维生素 E 与安慰剂的比较。此外，还有一项名为“GOALS”的遗传学研究，需要更多的儿童及其父母参与，以确定与 NASH 相关的候选基因，以及正在进行的数据库研究，涉及 1262 名当前受试者，旨在评估 NASH 的自然史。该数据库对于评估 NASH 的生活方式因素以及评估用于诊断和进展的非侵入性生物标志物和影像学也具有不可估量的价值。在本次更新中，我们的目标是扩大数据库，纳入代表性不足且经活检证实的重要亚人群，例如儿童（特别是女孩）、西班牙裔、黑人和肝硬化患者，以更好地了解年龄、性别、民族、种族、遗传和生活方式在 NASH 及其合并症发展中的作用。我们的目标是确定没有 NAFLD 的适当匹配的对照人群，以便与患有 NAFLD 的人群进行比较。我们建议进行另一项随机安慰剂对照临床试验，以评估 NASH 儿童的其他治疗方案，我们将完成、分析和报告上一个资助期的治疗研究，现已取得成果。