Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT06225193

Conditions

Fatty Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06225193

Start date

Jun 20, 2023

Status verified date

May, 2026

Completion date

Jun 23, 2026

Anticipated

Primary completion date

Jun 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Enhanced Liver Fibrosis (ELF )scores [ Time Frame: 6 months ]
  • Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy [ Time Frame: 6 months ]
  • Demographics [ Time Frame: 6 months ]
  • Instances of comorbidities [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Principal Investigator:

Parvez Mantry, MD

More Information

Sponsor

Methodist Health System

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2026-05-13.