Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-28 @ 7:30 AM
Study NCT ID:
NCT01629095
Status:
TERMINATED
Last Update Posted:
2020-11-27
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Studies of Non-Alcoholic Fatty Liver Disease
Sponsor:
National Human Genome Research Institute (NHGRI)
Organization:
Study Overview
Official Title:
Genetic Studies of Non-Alcoholic Fatty Liver Disease
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow/insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
\- 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.
Detailed Description:
Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common form of liver disease in the United States. It includes a wide spectrum of conditions from benign hepatic steatosis to cirrhosis and liver failure. Non-Alcoholic Steatohepatitis (NASH) is a term that describes specific histological characteristics of liver inflammation and seems to be a determinant step in the progression of NAFLD to cirrhosis and liver failure. The overall purpose of this study is to increase our understanding of the genetic background and pathophysiology of NAFLD through detailed review of physical, radiologic and pathology characteristics, when available. We will perform genetic analysis of known and candidate genes and will assess inheritance through evaluation of unaffected relatives. Most patients will be seen by hepatologists in transplant centers and hepatology clinics across the country. A subset of patients and their families may be seen at the NIH Clinical Center.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12-HG-0147 | None | None | View |