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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Methodist Health System
Study ID
NCT06225193
Status
Recruiting
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Conditions

  • Fatty Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 20, 2023
Status verified
May 2026
Primary completion
Jun 23, 2026
Completion
Jun 23, 2026

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

Enhanced Liver Fibrosis (ELF )scores [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Dallas Medical CenterDallasTexas75203
Jennifer N Kirchner
[email protected]
214-947-1280
Colette Ngo Ndjom, MS
[email protected]
217-947-4681
Parvez Mantry, MD (PRINCIPAL_INVESTIGATOR)

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