The Olmsted NAFLD Epidemiology Study (TONES)

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease
• Interventions: Diagnostic Test: Magnetic Resonance Elastography; Other: Blood draw; Procedure: Liver biopsy; Procedure: Fibro Scan

• Registration Number: NCT04365855
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Study Start: 2020-09-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects at risk for NAFLD	Magnetic Resonance Elastography	Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.
Subjects at risk for NAFLD	Liver biopsy	Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.
Subjects at risk for NAFLD	Blood draw	Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.
Subjects at risk for NAFLD	Fibro Scan	Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

Primary Outcome Measures

Name	Time	Method
Prevalence of NAFLD and NASH in the population	5 years	Number of subjects with NAFLD and NASH determined by the MRE

Secondary Outcome Measures

Name	Time	Method
Long-term health outcomes	5 years	Number of participants to experience the development of NAFLD, NASH, NASH cirrhosis complications, liver transplant, cardiovascular events, cancers or death

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States