The Olmsted NAFLD Epidemiology Study (TONES)

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

The Olmsted NAFLD Epidemiology Study (TONES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365855
• Other study ID #: 19-004848
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Jessica L Olson
• Phone: 507-266-3995
• Email: olson.jessica3[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of NAFLD and NASH in the population	Number of subjects with NAFLD and NASH determined by the MRE	5 years
Secondary	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