AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-22

Study Completion Date

2026-03-31

Brief Summary

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The purpose of this study is to create a resource that will advance research that is focused on discovery of novel therapies, risk stratification, and aggressive interventions for those at highest risk for non-alcoholic fatty liver disease (NAFLD). To achieve this, we will generate a biobank of liver tissue collected during standard of care liver biopsies. Paired blood/urine samples, FibroScan and relevant data will also be collected.

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Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Biopsy Group

Adults undergoing a standard of care liver biopsy at AdventHealth Central Florida Division for any reason

Standard of care liver biopsy

Intervention Type PROCEDURE

Patients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use.

Fibroscan

Intervention Type OTHER

A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.

Biospecimen Collection

Intervention Type OTHER

Blood and urine will be collected.

Non-Biopsy Group

Adults without any history of NAFLD

Fibroscan

Intervention Type OTHER

A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.

Biospecimen Collection

Intervention Type OTHER

Blood and urine will be collected.

Interventions

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Standard of care liver biopsy

Patients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use.

Intervention Type PROCEDURE

Fibroscan

A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.

Intervention Type OTHER

Biospecimen Collection

Blood and urine will be collected.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes