Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Utilizing Non-Invasive Fibroscan® Technology to Identify Genetic Markers for Fatty Liver Progression
Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting ~30% of people in
the general population and up to 96% of obese individuals. Variations in several genes have
been found to be associated with fatty liver, but these associations only explain a small
percentage of the risk, and further studies are needed. In many cases NAFLD does not cause
serious side effects, but in some individuals it progresses to scarring or hardening of the
liver, liver failure, and cancer.
The purpose of this research study is to determine if individuals who carry certain genetic
variations in a gene related to bile and choline metabolism have an increased risk of fatty
liver progressing to fibrosis, or scarring of the liver. This study will also use a new,
non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The
FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver
fat measurement. However, the FibroScan® instrument is considered a non-significant risk
device. Since its induction in Europe and worldwide in 2003, there have been no adverse
effects reported with this device.
Status | Completed |
Enrollment | 53 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Males and females - Ages 18-70 years - Body mass index 25-45 Exclusion Criteria: - Alcohol consumption > 20 grams/day - Liver disease from a cause other than NAFLD (such as hepatitis B/C, alcoholic liver disease, or autoimmune hepatitis) - Pharmacological therapy for liver disease - History of liver transplant - Presence of implantable medical devices - Ascites - Pregnancy - Smoking or use of recreational drugs |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | UNC Nutrition Research Institute | Kannapolis | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Nutrition Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver stiffness measurement via transient elastography | Measured by FibroScan® instrument | Study Day 1 | No |
Primary | Liver fat measurement via Controlled Attenuation Parameter | Measured using FibroScan® instrument | Study Day 1 | No |
Secondary | NAFLD-Fibrosis score | This is a calculated score which is a good predictor of liver disease | Study Day 1 | No |
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