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The Olmsted NAFLD Epidemiology Study (TONES)

NCT04365855 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-01-16

No results posted yet for this study

Summary

Researchers are assessing the prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) in the population and assembling a well-characterized cohort of adults with NAFLD and NASH to validate models of NAFLD diagnosis and determine long-term outcomes.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Non-Alcoholic Steatohepatitis

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Elastography

Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.

OTHER

Blood draw

Clinical blood tests with a focus on liver function parameters and diabetes

PROCEDURE

Liver biopsy

If indicated per MRE results a biopsy will be taken of the liver.

PROCEDURE

Fibro Scan

If indicated per MRE results a fibroscan will be performed of the liver.

Sponsors & Collaborators

Principal Investigators

  • ALINA M ALLEN, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-10
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365855 on ClinicalTrials.gov