Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score \>7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age: ≥ 18 years

• NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.

Locations
United States
Texas
Methodist Dallas Medical Center
RECRUITING
Dallas
Contact Information
Primary
Kavya Vinod Mankulangara, PharmD
MHSIRB@mhd.com
214-947-4681
Backup
Bethany Brauer, MPH
mhsirb@mhd.com
214-947-4681
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2026-06-23
Participants
Target number of participants: 300
Sponsors
Leads: Methodist Health System

This content was sourced from clinicaltrials.gov