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 range of liver conditions associated with fatty liver and includes steatosis and non-alcoholic steatosis (NASH). It is common in middle-aged and older individuals, especially those who are obese and have insulin resistance and type 2 diabetes. Based on NHANES III data for 2001, the prevalence of NAFLD is estimated at 23.5% of the US population. Liver biopsy is the gold standard for diagnosis. Currently there is no established therapy. A Clinical Research network has been established by the NIDDK to perform clinical, scientific, epidemiological and therapeutic research in NASH. The overall objective is to create an infrastructure for patient recruitment and retention in large multi-center trials using carefully defined and uniform criteria for the diagnosis of NASH. Specifically, this observational study is designed to investigate the etiology, natural history, diagnosis, treatment, and prevention of nonalcoholic fatty liver disease as defined by steatosis, steatohepatitis, and/or fibrosis and secondly, to develop a specimen bank comprising liver tissue, serum, plasma, and DNA obtained from NAFLD patients. Patients at least age 2 years with definite or suspected NAFLD or cryptogenic cirrhosis are eligible. Collection of biological specimens and data from questionnaires ( quality of life, activity level, eating habits and alcohol use) will be collected at screening, baseline evaluation, 6 months, 12 months and yearly for up to five years.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-44
Application #
7378002
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
44
Fiscal Year
2006
Total Cost
$65,422
Indirect Cost
Name
Case Western Reserve University
Department
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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