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

ConditionFatty Liver
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMethodist Health System

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with incomplete data and those lost to follow up.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
6 months
2

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

Time frame
6 months
3

Demographics

age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)

Time frame
6 months
4

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

Time frame
6 months

Secondary outcomes

1

Abnormalities in Liver ultrasound (U/S) findings

rate of liver damage

Time frame
6 months
2

Abnormalities in Liver biopsy results

Rate of cancerous cells in liver

Time frame
6 months

Other outcomes

Sponsors and contacts

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