Utilizing Non-Invasive Fibroscan® Technology to Identify Genetic Markers for Fatty Liver Progression
Completed
Conditions studied: Non-alcoholic Fatty Liver Disease
In brief
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.
Key facts
- Study ID
- NCT02267148
- Run by
- UNC Nutrition Research Institute
- People needed
- 53
- Starts
- 2014-10-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-01-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males and females
- Ages 18-70 years
- Body mass index 25-45
You may not qualify if…
- 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
Where it is running
- UNC Nutrition Research Institute — Kannapolis, North Carolina, United States
Full record on ClinicalTrials.gov
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