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

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.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver

Detailed Description

Methodist Health System consists of nine hospitals and over one hundred clinics that serve 7% to 10% of patients in the Dallas metropolitan. In November 2021, adopted the use of ELF tests in patients who had risk factors for NAFLD/NASH based on abnormal liver enzymes, metabolic risk factors, and evidence of hepatosteatosis on imaging. There is a knowledge gap in the literature when it comes to ELF scores in our population and the data we collect in this study will contribute to filling that knowledge gap.

Historically, assessment of fibrosis has been accomplished with FibroScan,elastography or liver biopsy. However, these tests are not widely available in most clinics, and can be invasive and costly. At present, the two primary inexpensive and non-invasive alternatives are the fibrosis-4 (FIB-4) and ELF scores, which employ algorithms that utilize routine lab draws. While a low FIB-4 score has a negative predictive value of 90% for advanced fibrosis, it does not provide a risk assessment of liver-related events. For this reason, the study explore the newer ELF serum test as a non-invasive, more affordable and available means to detect patients with developing fibrosis and as a predictor of liver-related outcomes that could be easily used in a primary care setting. This will better risk-stratify this patient population at the primary care level, without need for invasive and expensive testing, and will guide appropriate referrals to Hepatology.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Crystee Cooper; Phone Number: 2149471280; Email: crysteecooper@mhd.com
• Study Contact Backup: Name: Jennifer Kirchner; Phone Number: 74459 2149471280; Email: jenniferkirchner@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Principal Investigator: Parvez Mantry, MD
      • Contact: Jennifer N Kirchner; Phone Number: 74459 214-947-1280; Email: jenniferkirchner@mhd.com
      • Contact: Colette Ngo Ndjom, MS; Phone Number: 74459 217-947-4681; Email: mhsirb@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with 18 years of age, NAFLD/NASH and non-NAFLD/NASH who have assessed with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with incomplete data and those lost to follow up.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy	Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy	6 months
Demographics	age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)	6 months
Instances of comorbidities	Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities	6 months
Enhanced Liver Fibrosis (ELF )scores	Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormalities in Liver ultrasound (U/S) findings	rate of liver damage	6 months
Abnormalities in Liver biopsy results	Rate of cancerous cells in liver	6 months

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, MD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: 022.HEP.2023.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No