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NCT Number: NCT04365855

The Olmsted NAFLD Epidemiology Study (TONES)

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Steatohepatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

About this study

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. Recent information on the prevalence of NAFLD in general and Non-Alcoholic Steatohepatitis (NASH) with fibrosis in particular is very scarce. Such information is crucial for defining the epidemiology of NAFLD, identifying risk factors for advanced fibrosis and longitudinal outcomes. This study will enroll a random sample of adults from Olmsted County, Minnesota, to validate machine learning models for NAFLD diagnosis and disease severity. These data would be fundamental for the development of screening strategies in the community, which are urgently needed for early diagnosis of liver fibrosis and therapeutic interventions before cirrhosis develops.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Olmsted County residents at the time of search
  • Age 18 or older
  • No personal history of NAFLD diagnosis (administrative codes)

Exclusion criteria

  • Alcohol in excess (more than 20 gm per week in women and 30 gm per week in men)
  • Currently pregnant
  • Have contraindications to MRI (MRI incompatible implanted devices, severe claustrophobia)

Treatment and study plan

Magnetic Resonance Elastography

Diagnostic Test

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

Blood Draw

Other

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

Liver biopsy

Procedure

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

Fibro Scan

Procedure

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

Primary outcomes

  1. Prevalence of NAFLD and NASH in the population

    Time frame: 5 years

    Number of subjects with NAFLD and NASH determined by the MRE

Secondary outcomes

  1. Long-term health outcomes

    Time frame: 5 years

    Number of participants to experience the development of NAFLD, NASH, NASH cirrhosis complications, liver transplant, cardiovascular events, cancers or death

Study contacts

Contact information is provided by the study sponsor or research team.

Jodie A Cogswell

CONTACT

[email protected]

507-266-3995

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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