This application is for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) - Data Coordinating Center. Nonalcoholic fatty liver disease (NAFLD) affects one out of every three adults and five children in North America and is a growing public health issue in the United States. NAFLD, and especially nonalcoholic steatohepatitis (NASH), may lead to end-stage liver disease and primary liver cancer, as well as liver-, cardiovascular-, and cancer-related mortality, resulting in major increases in health burdens and costs. The NASH CRN is ideally and uniquely positioned to impact the growing public health significance of NASH that can only be addressed via a large research consortium. The primary objective of the NASH CRN is to perform clinical research on NASH and NAFLD in adults and children. A closely linked and high priority secondary objective is to conduct translational research in NASH and NAFLD focusing on the pathogenesis that will provide the basis for understanding the natural history and developing means of better diagnosis, treatment, and clinical management. In the next phase of the NASH CRN, the adult and pediatric therapeutic trials initiated during the previous funding cycle will be completed, and new therapeutic trials, including phase 2a proof of mechanism and phase 2b clinical trials will be initiated, to develop evidence-based treatment options that are safe, effective, simple, and inexpensive. The longitudinal cohort of adults and children with NAFLD will be extended, which will prospectively define the natural history of the disease, the cardiovascular and metabolic risk factors, and will aid in biomarker discovery and validation, and development and validation of non-invasive techniques to evaluate and identify those with NASH/NAFLD, who will respond, and how quickly the disease is progressing. The Data Coordinating Center will provide the NASH CRN with leadership, expertise (in biostatistical analysis, study design, data management, multicenter coordination, quality control methods) and project support, communication and organization and is eager to continue its collaboration with the clinical centers, NIDDK program staff, and private sector partners to complete these very important research objectives. The NASH CRN is poised to continue its major impact on the field and directly advance the mission of the National Institutes of Health to improve the health of the public.

Public Health Relevance

Nonalcoholic fatty liver disease (NAFLD) affects one in three adults and one in five children in North America. NAFLD, and especially nonalcoholic steatohepatitis (NASH), is associated with increased liver-, cardiovascular-, and cancer-related mortality. The NASH CRN aims to transform scientific discoveries from laboratory, clinical, and population studies into clinical applications to reduce the incidence and burden of adverse outcomes due to NAFLD and NASH.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK061730-13
Application #
8774345
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Doo, Edward
Project Start
2002-05-01
Project End
2019-06-30
Budget Start
2014-08-01
Budget End
2015-06-30
Support Year
13
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Hameed, B; Terrault, N A; Gill, R M et al. (2018) Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis. Aliment Pharmacol Ther 47:645-656
Africa, Jonathan A; Behling, Cynthia A; Brunt, Elizabeth M et al. (2018) In Children With Nonalcoholic Fatty Liver Disease, Zone 1 Steatosis Is Associated With Advanced Fibrosis. Clin Gastroenterol Hepatol 16:438-446.e1
Ajmera, Veeral; Belt, Patricia; Wilson, Laura A et al. (2018) Among Patients With Nonalcoholic Fatty Liver Disease, Modest Alcohol Use Is Associated With Less Improvement in Histologic Steatosis and Steatohepatitis. Clin Gastroenterol Hepatol 16:1511-1520.e5
Arsik, Idil; Frediani, Jennifer K; Frezza, Damon et al. (2018) Alanine Aminotransferase as a Monitoring Biomarker in Children with Nonalcoholic Fatty Liver Disease: A Secondary Analysis Using TONIC Trial Data. Children (Basel) 5:
Rausch, John C; Lavine, Joel E; Chalasani, Naga et al. (2018) Genetic Variants Associated With Obesity and Insulin Resistance in Hispanic Boys With Nonalcoholic Fatty Liver Disease. J Pediatr Gastroenterol Nutr 66:789-796
Vuppalanchi, Raj; Siddiqui, Mohammad S; Van Natta, Mark L et al. (2018) Performance characteristics of vibration-controlled transient elastography for evaluation of nonalcoholic fatty liver disease. Hepatology 67:134-144
Brunt, Elizabeth M; Kleiner, David E; Wilson, Laura A et al. (2018) Improvements in Histologic Features and Diagnosis associated with Improvement in Fibrosis in NASH: Results from the NASH Clinical Research Network Treatment Trials. Hepatology :
Harlow, Kathryn E; Africa, Jonathan A; Wells, Alan et al. (2018) Clinically Actionable Hypercholesterolemia and Hypertriglyceridemia in Children with Nonalcoholic Fatty Liver Disease. J Pediatr 198:76-83.e2
Middleton, Michael S; Van Natta, Mark L; Heba, Elhamy R et al. (2018) Diagnostic accuracy of magnetic resonance imaging hepatic proton density fat fraction in pediatric nonalcoholic fatty liver disease. Hepatology 67:858-872
Haufe, William M; Wolfson, Tanya; Hooker, Catherine A et al. (2017) Accuracy of PDFF estimation by magnitude-based and complex-based MRI in children with MR spectroscopy as a reference. J Magn Reson Imaging 46:1641-1647

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