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Utilizing Non-Invasive Fibroscan® Technology to Identify Genetic Markers for Fatty Liver Progression

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ClinicalTrials.gov Identifier: NCT02267148
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Karen D. Corbin, PhD, RD, UNC Nutrition Research Institute

Brief Summary:

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.


Condition or disease
Non-alcoholic Fatty Liver Disease

Detailed Description:

Purpose: ABCB4 is a gene that intersects choline and bile metabolism, two processes that are highly relevant for liver disease. The investigators have identified a pattern of genetic variation that is associated with fatty liver burden and potentially, risk for liver disease. One of the most prominent genes in this pattern is ABCB4. This data needs to be replicated in the general population. This study will test the hypothesis that aberrant function of ABCB4 due to genetic variations will increase the risk of fatty liver progression to fibrosis. It will also implement innovative, non-invasive technology to measure liver fat and fibrosis utilizing the FibroScan® instrument. As additional proof of principle that the measurements we are making correlate with genetics, the investigators will also measure two genetic variants that have been shown in many studies to correlate with liver fat and fibrosis by their research team and others: PNPLA3 rs738409 and rs2281135. Finally, the investigators will calculate a NAFLD-Fibrosis score as an additional correlate to liver disease status.

Participants: To test this hypothesis, 50 ethnically diverse, overweight or obese male and female adults will be recruited from the general population.

Procedures: Genotyping to correlate variation in the ABCB4 and PNPLA3 genes with level of fatty liver and progression to fibrosis with the FibroScan®. Calculation of NAFLD-Fibrosis score.


Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Utilizing Non-Invasive Fibroscan® Technology to Identify Genetic Markers for Fatty Liver Progression
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014





Primary Outcome Measures :
  1. Liver stiffness measurement via transient elastography [ Time Frame: Study Day 1 ]
    Measured by FibroScan® instrument

  2. Liver fat measurement via Controlled Attenuation Parameter [ Time Frame: Study Day 1 ]
    Measured using FibroScan® instrument


Secondary Outcome Measures :
  1. NAFLD-Fibrosis score [ Time Frame: Study Day 1 ]
    This is a calculated score which is a good predictor of liver disease


Biospecimen Retention:   Samples With DNA
Whole blood will be collected and used for DNA extraction. Plasma and serum will also be collected and banked.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of the greater Charlotte, NC metropolitan area
Criteria

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

Information from the National Library of Medicine

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): NCT02267148


Locations
United States, North Carolina
UNC Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
UNC Nutrition Research Institute
Investigators
Principal Investigator: Karen Corbin, PhD, RD UNC Nutrition Research Institute

Responsible Party: Karen D. Corbin, PhD, RD, Research Assistant Professor, UNC Nutrition Research Institute
ClinicalTrials.gov Identifier: NCT02267148     History of Changes
Other Study ID Numbers: 13-1392
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Karen D. Corbin, PhD, RD, UNC Nutrition Research Institute:
Non-alcoholic fatty liver disease
Fatty liver
Steatosis
Fibrosis
Liver Stiffness
Cirrhosis
Genetics
Single Nucleotide Polymorphism

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases