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Recruiting NCT04365855

The Olmsted NAFLD Epidemiology Study (TONES)

No phase Interventional Non-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Elastography, Blood draw, Liver biopsy, Fibro Scan.
Who it may be relevant to
Registry conditions: Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Prevalence of NAFLD and NASH in the population [Time frame: 5 years]
Secondary outcome measures (1)
  • Long-term health outcomes [Time frame: 5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT04365855 · 19-004848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗