Genetic Studies of Non-Alcoholic Fatty Liver Disease

Stopped early

Conditions studied: Non-Alcoholic Steato-Hepatitis, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease

In brief

Background: \- Non-alcoholic fatty liver disease is the most common form of liver disease in the United States. It includes many conditions. Researchers want to study fatty liver disease by looking at people who have liver cirrhosis. They also want to look at people who are or were listed for liver transplants. Genetic studies may provide more information on the causes of these conditions. Objectives: \- To study possible genetic causes of non-alcoholic fatty liver disease. Eligibility: \- Individuals of any age who have non-alcoholic fatty liver disease and related conditions. Design: * Participants will be screened with a physical exam and medical history. * Participants will provide a blood sample for genetic testing. Liver tissue from a transplant or biopsy may also be studied. * Participants may also be asked to have an imaging study of the liver. This imaging study may be an x-ray or magnetic resonance imaging. * No treatment will be provided as part of this research study.

Key facts

Study ID

NCT01629095

Run by

National Human Genome Research Institute (NHGRI)

People needed

17

Starts

2013-04-23

Expected to finish

2017-01-09

Last updated by the study team

2020-11-27

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Anyone unwilling to provide informed consent (for themselves as adults, or on behalf of their children as minors) or assent.
• Pregnant women. Although fatty liver and cirrhosis are sometimes diagnosed during pregnancy, it is unclear if they were present before and just not diagnosed or if they develop as a complication of pregnancy. Additionally energy metabolism changes during pregnancy and lactation which may confound our analysis. If the condition persists after pregnancy and the diagnosis of NAFLD is
• clearly established, patients can be referred to the study.
• We will review a clinical description from the referring physician about a potential research subject to determine that the subject is appropriate to enter into the study. We reserve the right to exclude cases that are clearly not NAFLD or related to our direct research interests (e.g. fatty liver induced by chronic alcohol use, infectious causes, drug-related, or toxin-related). This almost never happens. However, as some of these environmental factors may contribute to a multifactorial etiology of hepatic changes, we may not exclude all such cases.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic Transplantation Clinic — Cleveland, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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