NCT04365855

The Olmsted NAFLD Epidemiology Study (TONES)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-10
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2020-04-28
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States