NCT06225193 Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population
| NCT ID | NCT06225193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Methodist Health System |
| Condition | Fatty Liver |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2026-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-06-20 with a primary completion date of 2026-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Parvez Mantry, MD
PRINCIPAL INVESTIGATOR
Methodist Midlothian Medical Center
Frequently Asked Questions
Who can join the NCT06225193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fatty Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06225193 currently recruiting?
Yes, NCT06225193 is actively recruiting participants. Contact the research team at crysteecooper@mhd.com for enrollment information.
Where is the NCT06225193 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06225193 clinical trial?
NCT06225193 is sponsored by Methodist Health System. The principal investigator is Parvez Mantry, MD at Methodist Midlothian Medical Center. The trial plans to enroll 300 participants.