Genetic Studies of Non-Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT01629095|
Recruitment Status : Terminated (Slow/insufficient accrual)
First Posted : June 27, 2012
Last Update Posted : November 27, 2020
- 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.
- To study possible genetic causes of non-alcoholic fatty liver disease.
- Individuals of any age who have non-alcoholic fatty liver disease and related conditions.
- 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.
|Condition or disease|
|Non-Alcoholic Steato-Hepatitis Liver Cirrhosis Non-Alcoholic Fatty Liver Disease|
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Genetic Studies of Non-Alcoholic Fatty Liver Disease|
|Actual Study Start Date :||April 23, 2013|
|Actual Primary Completion Date :||January 9, 2017|
|Actual Study Completion Date :||January 9, 2017|
Patients who have already undergone liver transplantation for a confirmed diagnosis of NAFLD or cryptogenic cirrhosis are also eligible to participate.
Patients with radiologic evidence of fatty liver and/or cirrhosis in which other causes havebeen ruled out are eligible to participate.
- To better understand the underlying mechanisms of liver regeneration and the development of NASH. [ Time Frame: One point in time ](a) To determine the role of the Sonic Hedgehog signaling pathway and related genes in the predisposition to liver injury and NASH.(b) To compare gene variants (with known or suspected abnormal functional effects) with the phenotypes observed in patients (i.e. genotype- phenotype correlations) as documented in the study.(c) To verify recurrence risks /inheritance patterns for each of the candidate genes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629095
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599-7030|
|United States, Ohio|
|Cleveland Clinic Transplantation Clinic|
|Cleveland, Ohio, United States|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States|
|Principal Investigator:||Paul S Kruszka, M.D.||National Human Genome Research Institute (NHGRI)|