This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. NAFLD appears to be highly prevalent within the United States. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]; nonalcoholic steatosis [NAS]), and nonalcoholic steatohepatitis (NASH) in which there is ballooning degeneration (with or without Mallory bodies) and/or fibrosis. In severe cases, NASH may progress to cirrhosis, in which steatosis may be present or absent. In the latter circumstance, end stage NASH may evolve into and contribute to one category of cryptogenic cirrhosis. The pathology of NASH closely resembles alcoholic liver disease but occurs in patients who drink little or no alcohol. NASH is most common in adults above the age of 40 who are overweight or have diabetes, insulin resistance or hyperlipidemia. However, the disease also occurs in children and in persons who are not obese or diabetic. Currently, there is no established effective therapy for NASH, and its natural history and prognosis are not well understood. In 2002, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through the mechanism of RFA DK 01 025, established a Clinical Research Network (CRN), the goal of which is to facilitate and perform clinical, scientific, epidemiological and therapeutic research in NASH. The NASH Clinical Research Network (NASH CRN) is a cooperative network of eight clinical centers and one Data Coordinating Center (DCC). Clinical centers are responsible for proposing protocols, participating in their overall development, recruiting patients, conducting the research, and disseminating research findings. The individual clinical centers participate in a cooperative and interactive manner with one another and with the DCC in all aspects of the NASH CRN. The DCC supports protocol development; provides sample size calculations, statistical expertise, forms, and data analysis; supports manuscript preparation; and provides overall study coordination and quality assurance, including coordination of the activities of the Data and Safety Monitoring Board, the Steering Committee and other standing committees. The DCC also collaborates with the NIDDK Biosample (plasma, serum, and liver tissue) and Genetics (DNA) Repositories. A Steering Committee composed of the principal investigators of each clinical center in the Network, the principal investigator of the DCC, and the NIDDK Project Scientist is the main governing body of the NASH CRN. The Steering Committee has primary responsibility for the general organization of the NASH CRN, finalizing common clinical protocols and facilitating the development of a standardized nomenclature, diagnostic criteria, histological definitions, and the necessary components to the common database on patients. The Steering Committee is responsible for the conduct and monitoring of studies and reporting study results.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-45
Application #
7378877
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
45
Fiscal Year
2006
Total Cost
$3,562
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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