The Olmsted NAFLD Epidemiology Study (TONES)

ConditionsNon-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Olmsted County residents at the time of search

Age 18 or older

No personal history of NAFLD diagnosis (administrative codes)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Magnetic Resonance Elastography
Diagnostic test
Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.
Blood draw
Other intervention
Clinical blood tests with a focus on liver function parameters and diabetes
Liver biopsy
Procedure/Surgery
If indicated per MRE results a biopsy will be taken of the liver.
Fibro Scan
Procedure/Surgery
If indicated per MRE results a fibroscan will be performed of the liver.

Treatment groups

800 Participants

are divided into 1 treatment group

Group A: Subjects at risk for NAFLDOther 4 interventions

Trial outcomes

Primary outcomes

Prevalence of NAFLD and NASH in the population

Number of subjects with NAFLD and NASH determined by the MRE

Time frame

5 years

Secondary outcomes

Long-term health outcomes

Number of participants to experience the development of NAFLD, NASH, NASH cirrhosis complications, liver transplant, cardiovascular events, cancers or death

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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