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NCT04365855 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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