Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04365855

Conditions

Non-Alcoholic Fatty Liver Disease

Non-Alcoholic Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Elastography

Blood draw

Liver biopsy

Fibro Scan

Study Details

Brief 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

Study ID

NCT04365855

Start date

Oct 10, 2020

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

800 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Subjects at risk for NAFLD

Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

Interventions

Magnetic Resonance Elastography

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

Blood draw

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

Liver biopsy

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

Fibro Scan

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

Primary outcome measure

  • Prevalence of NAFLD and NASH in the population [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jodie A Cogswell

507-266-3995cogswell.jodie@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-16.