Non-Alcoholic Fatty Liver DiseaseNCT04365855
The Olmsted NAFLD Epidemiology Study (TONES)
A study testing Magnetic Resonance Elastography, Blood draw and Liver biopsy in people with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- What is being tested?
- Magnetic Resonance Elastography, Blood draw and Liver biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Olmsted County residents at the time of search
- Age 18 or older
- No personal history of NAFLD diagnosis (administrative codes)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Being tested
- Magnetic Resonance Elastography, Blood draw, Liver biopsy, Fibro Scan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ElastographyDiagnostic test
Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.
Blood drawOther
Clinical blood tests with a focus on liver function parameters and diabetes
Liver biopsyProcedure or surgery
If indicated per MRE results a biopsy will be taken of the liver.
Fibro ScanProcedure or surgery
If indicated per MRE results a fibroscan will be performed of the liver.
| Study group | Role | What they receive |
|---|---|---|
| Subjects at risk for NAFLD | Other | Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy. Receives: Diagnostic Test: Magnetic Resonance Elastography; Other: Blood draw; Procedure: Liver biopsy; Procedure: Fibro Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD and NASH in the population
Number of subjects with NAFLD and NASH determined by the MRE
Measured: 5 years
Secondary outcomes (1)
Long-term health outcomes
Number of participants to experience the development of NAFLD, NASH, NASH cirrhosis complications, liver transplant, cardiovascular events, cancers or death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start10 Oct 2020
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alina M. Allen, Mayo Clinic
- Investigators
- ALINA M ALLEN, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365855
- Sponsor's protocol ID
- 19-004848
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Olmsted NAFLD Epidemiology Study (TONES)
- ClinicalTrials.gov ID
- NCT04365855
- Acronym / sponsor ID
- 19-004848
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subjects at risk for NAFLD | Other | Diagnostic Test: Magnetic Resonance Elastography, Other: Blood draw, Procedure: Liver biopsy, Procedure: Fibro ScanAdult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Olmsted County residents at the time of search
- Age 18 or older
- No personal history of NAFLD diagnosis (administrative codes)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ElastographyCombines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues. | Diagnostic test | Subjects at risk for NAFLD |
| Blood drawClinical blood tests with a focus on liver function parameters and diabetes | Other | Subjects at risk for NAFLD |
| Liver biopsyIf indicated per MRE results a biopsy will be taken of the liver. | Procedure or surgery | Subjects at risk for NAFLD |
| Fibro ScanIf indicated per MRE results a fibroscan will be performed of the liver. | Procedure or surgery | Subjects at risk for NAFLD |
Primary outcome
Prevalence of NAFLD and NASH in the population
Time frame: 5 years
Number of subjects with NAFLD and NASH determined by the MRE
1 secondary outcome
Long-term health outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ALINA M ALLEN, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Elastography, Blood draw and Liver biopsy in people with Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodie A Cogswell (507-266-3995, cogswell.jodie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD and NASH in the population (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.