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Diagnostic Techniques for Fatty Liver Disease

N/A
Recruiting
Led By ALINA M ALLEN, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
No personal history of NAFLD diagnosis (administrative codes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is assessing the prevalence of two liver diseases, Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH), and assembling a cohort of adults with these diseases to better understand them.

Who is the study for?
This study is for adults over 18 living in Olmsted County without a previous NAFLD diagnosis. It's not for those with MRI-incompatible devices, severe claustrophobia, heavy alcohol users (over 20g/week for women and 30g/week for men), or pregnant individuals.
What is being tested?
The TONES study is looking at how common NAFLD and NASH are among people. It uses Magnetic Resonance Elastography, blood tests, Fibro Scan, and liver biopsies to build a detailed picture of these liver conditions.
What are the potential side effects?
Possible side effects include discomfort from the Fibro Scan or biopsy procedure, bruising from blood draws, and anxiety or discomfort during an MRI scan due to noise or confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have never been diagnosed with fatty liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of NAFLD and NASH in the population
Secondary study objectives
Long-term health outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects at risk for NAFLDExperimental Treatment4 Interventions
Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fibro Scan
2015
N/A
~220
Liver biopsy
2018
N/A
~1330

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,061,549 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
349 Patients Enrolled for Non-alcoholic Fatty Liver Disease
ALINA M ALLEN, MDPrincipal InvestigatorMayo Clinic

Media Library

Liver biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04365855 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: Subjects at risk for NAFLD
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Liver biopsy Highlights & Side Effects. Trial Name: NCT04365855 — N/A
Liver biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04365855 — N/A
~365 spots leftby Jun 2028
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