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

NCT06225193 | Recruiting

• 1 other identifier: 022.HEP.2023.D
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (2)

• Abnormalities in Liver ultrasound (U/S) findings

  6 months

• Abnormalities in Liver biopsy results

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Parvez Mantry, MD

  Methodist Midlothian Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kavya Vinod Mankulangara, PharmD

CONTACT

214-947-4681; MHSIRB@mhd.com

Bethany Brauer, MPH

CONTACT

214-947-4681; mhsirb@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: January 25, 2024
• Study Start: June 20, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)