Multicenter, Prospective Study to Investigate the Etiology, Pathogenesis, Natural History, Diagnosis, Treatment and Prevention of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH)
The purpose of the NAFLD Database 3 is to better understand nonalcoholic fatty liver disease (NAFLD) by following and evaluating people yearly with this condition. Database 3 is an observational study that attempts to elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications. The main purpose of this study is to learn more about fatty liver disease by collecting information from patients with this condition locally.
This study is a nationwide study funded by the National Institutes of Health (NIH). This study will not attempt to change the patient’s current treatment. There will be a tissue bank for storing of some of your blood, DNA, and liver specimens. These specimens will be taken at the same time as the research visit so that there is no need to take extra tissue from the patient. Any available liver tissue will be obtained from your hospital, where it is usually kept after the liver biopsy, as part of the participants’ medical record.
Minimum follow-up on a participant will be 48 weeks, and maximum follow-up on a participant will be 192 weeks. We aim to enroll 200 patients into the study. Patients must have a biopsy to support the NAFLD/NASH diagnose and must have a biopsy within 90 days of the screening visit in order to be enrolled in to the study. To be eligible for this study you must be at least 18 years old and must have NAFLD or NASH-related cirrhosis. You cannot have consumed significant amounts of alcohol within the past two years. We will ask you questions to check that you are not drinking significant amounts of alcohol during the study.
The NAFLD Database study consists of up to four follow-up visits. The screening visit will take approximately 2 hours with each follow up visit taking approximately 1.5 hours. Study participants will be asked to come in a fasting state for the blood draw and will receive a physical exam and undergo imaging (magnetic resonance techniques and ultrasound). In addition, participants will be asked questions about alcohol consumption and medication use.
Note: We are currently enrolling patients for this study.
For additional questions regarding this study please contact:
Phone: (858) 246-5417