Biobank and registry for non-alcoholic fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a biobank and registry to support research on non-alcoholic fatty liver disease (NAFLD). It will collect liver tissue samples during standard care biopsies, along with paired blood and urine samples, and relevant data such as FibroScan results. The goal is to advance the discovery of new therapies and improve risk stratification for patients at high risk for NAFLD. Participants will include both those undergoing liver biopsies and those with elevated BMI but without NAFLD.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Females and Males ≥ 18 years of age.
* Understands the procedures and agrees to participate by giving written informed consent.

Biopsy Group Only:

• Scheduled for standard of care liver biopsy for any reason.

Non-Biopsy Group Only:

• BMI ≥ 25, with or without type 2 diabetes, without any level of NAFLD based on: (1) Recent medical history (within 6 months of screening visit). (2) Data collected from participation in a prior research study where they consented to be re-contacted for future studies.

Exclusion Criteria

* Women who are pregnant when referred for a liver biopsy will be excluded.
* Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

Otherwise, all eligible patients who consent will be included in AVAIL. If participants in the non-biopsy group are found to have NAFLD based on the FibroScan done for this study, then they will be informed of this and advised to follow up with their physician. Their data will still be part of the registry and analyzed with the biopsy group that is found to have NAFLD.

Where it's running

• AdventHealth Translational Research Institute
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Karen Corbin, PhD, RD — Investigator
• Study coordinator: Recruitment Department
• Email: Fh.tri.recruitment@adventhealth.com
• Phone: 407-303-7100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.