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

NCT02267148 | Completed

• 1 other identifier: 13-1392
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease; Fatty liver; Steatosis; Fibrosis; Liver Stiffness; Cirrhosis; Genetics; Single Nucleotide Polymorphism

Outcome Measures

Primary Outcomes (2)

• Liver stiffness measurement via transient elastography

  Measured by FibroScan® instrument

  Study Day 1

• Liver fat measurement via Controlled Attenuation Parameter

  Measured using FibroScan® instrument

  Study Day 1

Secondary Outcomes (1)

• NAFLD-Fibrosis score

  Study Day 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of the greater Charlotte, NC metropolitan area

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

Sponsors & Collaborators

• UNC Nutrition Research Institute: lead

Study Sites (1)

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be collected and used for DNA extraction. Plasma and serum will also be collected and banked.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Corbin, PhD, RD

  UNC Nutrition Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

US (1)