The Olmsted NAFLD Epidemiology Study (TONES)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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

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Non-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

We will invite adult Olmsted County residents with research authorization, identified based on a random search of the Rochester Epidemiology Project database. We plan to accrue 800 participants. Based on literature estimates, approximately 25-30% of adults will be at risk for NAFLD due to overweight/obese status. Participants will undergo tests for NAFLD screening: blood tests, Magnetic Resonance Imaging/Elastography and electrocardiogram. Those identified with fatty liver will undergo Transient elastography and liver biopsy for disease severity assessment. These results will be used to validate a machine learning model of NAFLD diagnosis and liver disease severity which uses the participants clinical and laboratory data (noninvasive electronic health records). The cohort will be followed for 5 years, when they will return for repeat imaging and blood tests to monitor for incident NAFLD, liver disease progression and outcomes.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Magnetic Resonance Elastography

Intervention Type DIAGNOSTIC_TEST

Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.

Blood draw

Intervention Type OTHER

Clinical blood tests with a focus on liver function parameters and diabetes

Liver biopsy

Intervention Type PROCEDURE

If indicated per MRE results a biopsy will be taken of the liver.

Fibro Scan

Intervention Type PROCEDURE

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

Interventions

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Magnetic Resonance Elastography

Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.

Intervention Type DIAGNOSTIC_TEST

Blood draw

Clinical blood tests with a focus on liver function parameters and diabetes

Intervention Type OTHER

Liver biopsy

If indicated per MRE results a biopsy will be taken of the liver.

Intervention Type PROCEDURE

Fibro Scan

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No