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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevalence of NAFLD and NASH in the population

Secondary outcome measures

Long-term health outcomes

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

2016

N/A

~1180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,238 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any recruitment efforts taking place for this experiment?

"Yes, according to clinicaltrials.gov, this medical research is still recruiting participants. It was initially posted on September 29th 2020 and the most recent update was April 14th 2022. Currently 800 patients need to be recruited from one trial site."

Answered by AI

What is the current enrollment for this research endeavor?

"Affirmative. Evidence on clinicaltrials.gov states that this experiment is recruiting volunteers, with the initial posting having been made on September 29th 2020 and last edited April 14th 2022. 800 individuals are sought to take part at one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Olmsted NAFLD Epidemiology Study (TONES)

Alina M. Allen 2020. "The Olmsted NAFLD Epidemiology Study (TONES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04365855.

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