Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network: Nonin
非酒精性脂肪性肝炎临床研究网络的延续:Nonin
基本信息
- 批准号:7741915
- 负责人:
- 金额:$ 41.13万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2002
- 资助国家:美国
- 起止时间:2002-06-15 至 2014-04-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAdultAffectAmericanAncillary StudyAreaAttentionBiological MarkersBiopsyBurn injuryCardiacCardiovascular DiseasesCardiovascular systemCaringChildChronicCirrhosisClinicClinicalClinical ResearchClinical TrialsClinical Trials DatabaseControl GroupsDataDatabasesDevelopmentDiabetes MellitusDiagnosisDiffusionDiseaseDisease ProgressionDouble-Blind MethodElementsEnrollmentEvaluationFatty LiverFeasibility StudiesFundingFutureGeneticGoalsHealthHistologyImageIncidenceIndividualInvestigationLengthLiverLiver FibrosisLiver diseasesLongitudinal StudiesMagnetic Resonance ImagingMass Spectrum AnalysisMetabolicMethodsModificationMonitorMyocardialMyocardiumNational Institute of Diabetes and Digestive and Kidney DiseasesNatural HistoryNorth AmericaPathogenesisPatientsPerformancePhasePhenotypePilot ProjectsPreventionProteomicsProtocols documentationProtonsPublicationsRandomizedRandomized Clinical TrialsReportingResearchRiskRisk FactorsSamplingSerumSeveritiesSeverity of illnessSiteSpecificityStagingSystems BiologyTechniquesTestingTherapeutic StudiesTherapy Clinical TrialsTissuesTriglyceridesUnderrepresented MinorityUnited StatesUnited States Dept. of Health and Human ServicesUnited States National Institutes of HealthWorkbariatric surgerybaseclinical materialcohortcytokinedisease natural historyeffective therapyfollow-upgenome wide association studyinsulin sensitizing drugslipid disorderliver biopsymeetingsmetabolomicsnon-alcoholic fatty livernon-diabeticnonalcoholic steatohepatitisnovelprospectivepublic health relevancesobrietysuccesstool
项目摘要
DESCRIPTION (provided by applicant):
Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are important causes of chronic liver disease in the United States. The NASH Clinical Research Network (NASH CRN) was established in 2002 to conduct research related to its clinical features, risk factors, pathogenesis, natural history and treatment in children and adults. The initial funding period of the NASH CRN has been very productive in establishing and conducting network-wide protocols and numerous ancillary and pilot studies. Encouraged by its success, the NIDDK has issued RFA-DK-08-505 whose objective is to continue the NASH CRN for additional five years. The objectives of the NASH CRN during the next funding period are (a) to successfully complete three network-wide studies initiated during the initial funding period. They are an observational longitudinal study of NAFLD in adults and children (NAFLD Database study, n=1,215), a randomized double blind controlled therapeutic study of NASH in non-diabetic adults (PIVENS, n=247), and a randomized double blind controlled therapeutic study of NAFLD in children (TONIC, n=173). The NAFLD Database study may be amended to meet additional goals during the next funding period. These modifications may include extending the length of follow-up of those enrolled, consideration of a follow-up liver biopsy in a subset of patients without cirrhosis for better assessment of histological natural history and enrolling carefully chosen controls without NAFLD; (b) to successfully complete a large of ancillary studies and pilot studies that have been begun during the initial funding period; (c) to conduct additional therapeutic studies in adults and children with NASH as options currently available to treat NASH are quite limited. Subsets of patients requiring immediate attention include (but not limited) to those with diabetes or cirrhosis and (d) to initiate and complete additional ancillary studies based on extensive clinical material and biosamples collected thus far. These studies may focus on (but are not limited to) natural history of NAFLD and NASH in children and adults, non-invasive assessment of disease severity (e.g., proteomics, lipodimics, clinical prediction rules) and disease pathogenesis (cytokine analyses, genome-wide association studies, tissue proteomics). Two new ancillary studies proposed by the UCSF Clinical Center aim to: a) Develop a non-invasive alternative to liver biopsy for the evaluation and monitoring of hepatic fibrosis in NAFLD CRN patients using novel MRI imaging and MR spectroscopic techniques, and b) Elucidate the impact of NAFLD on cardiac lipotoxicity, cardiac energetics, and myocardial function in NASH CRN patients using cardiac MRI and proton mass spectroscopy.
描述(由申请人提供):
非酒精性脂肪性肝病(NAFLD)和非酒精性脂肪性肝炎(NASH)是美国慢性肝病的重要原因。NASH临床研究网络(NASH CRN)成立于2002年,旨在开展与儿童和成人的临床特征,风险因素,发病机制,自然史和治疗相关的研究。NASH CRN的初始资助期在建立和实施网络范围的协议以及许多辅助和试点研究方面非常富有成效。受其成功的鼓舞,NIDDK发布了RFA-DK-08-505,其目标是将NASH CRN再延续五年。NASH CRN在下一个资助期内的目标是:(a)成功完成初始资助期内启动的三项全网络研究。它们是成人和儿童NAFLD的观察性纵向研究(NAFLD数据库研究,n= 1,215),非糖尿病成人NASH的随机双盲对照治疗研究(PIVENS,n=247)和儿童NAFLD的随机双盲对照治疗研究(TONIC,n=173)。NAFLD数据库研究可能会进行修改,以满足下一个资助期内的其他目标。这些修改可以包括延长那些入选者的随访时间,考虑在没有肝硬化的患者亚组中进行随访肝活检以更好地评估组织学自然史,以及入选精心选择的没有NAFLD的对照;(B)成功完成在初始资助期间已经开始的大量辅助研究和试点研究;(c)在患有NASH的成人和儿童中进行额外的治疗研究,因为目前治疗NASH的选择非常有限。需要立即关注的患者亚组包括(但不限于)糖尿病或肝硬化患者,以及(d)根据迄今为止收集的大量临床资料和生物样本启动并完成额外的辅助研究。这些研究可能集中于(但不限于)儿童和成人NAFLD和NASH的自然史、疾病严重程度的非侵入性评估(例如,蛋白质组学、脂质组学、临床预测规则)和疾病发病机制(细胞因子分析、全基因组关联研究、组织蛋白质组学)。UCSF临床中心提出的两项新的辅助研究旨在:a)开发一种非侵入性替代肝活检的方法,用于使用新型MRI成像和MR光谱技术评价和监测NAFLD CRN患者的肝纤维化,以及B)使用心脏MRI和质子质谱阐明NAFLD对NASH CRN患者的心脏脂毒性、心脏能量学和心肌功能的影响。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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NATHAN M BASS其他文献
NATHAN M BASS的其他文献
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{{ truncateString('NATHAN M BASS', 18)}}的其他基金
Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network: Nonin
非酒精性脂肪性肝炎临床研究网络的延续:Nonin
- 批准号:
8012942 - 财政年份:2010
- 资助金额:
$ 41.13万 - 项目类别:
NONALCOHOLIC FATTY LIVER DISEASE (NAFLD) DATABASE
非酒精性脂肪肝 (NAFLD) 数据库
- 批准号:
7202687 - 财政年份:2005
- 资助金额:
$ 41.13万 - 项目类别:
PIOGLITAZONE VERSUS VITAMIN E VERSUS PLACEBO FOR THE TREATMENT OF NONDIABETIC
吡格列酮与维生素 E 与安慰剂治疗非糖尿病患者的比较
- 批准号:
7202681 - 财政年份:2005
- 资助金额:
$ 41.13万 - 项目类别:
Ursodeoxycholate and Methotrexate for Biliary Cirrhosis
熊去氧胆酸和甲氨蝶呤治疗胆汁性肝硬化
- 批准号:
6972227 - 财政年份:2004
- 资助金额:
$ 41.13万 - 项目类别:
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