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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Elastography; Other: Blood draw; Procedure: Liver biopsy; Procedure: Fibro Scan

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 Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica L Olson; Phone Number: 507-266-3995; Email: olson.jessica3@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of NAFLD and NASH in the population	Number of subjects with NAFLD and NASH determined by the MRE	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: ALINA M ALLEN, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 19-004848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No