NCT04365855

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2020Jun 2028

First Submitted

Initial submission to the registry

April 9, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7.6 years

First QC Date

April 9, 2020

Last Update Submit

January 14, 2026

Conditions

Non-Alcoholic Fatty Liver DiseaseNon-Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of NAFLD and NASH in the population

    Number of subjects with NAFLD and NASH determined by the MRE

    5 years

Secondary Outcomes (1)

  • Long-term health outcomes

    5 years

Study Arms (1)

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.

Diagnostic Test: Magnetic Resonance ElastographyOther: Blood drawProcedure: Liver biopsyProcedure: Fibro Scan

Interventions

Magnetic Resonance ElastographyDIAGNOSTIC_TEST

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

Subjects at risk for NAFLD
Blood drawOTHER

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

Subjects at risk for NAFLD
Liver biopsyPROCEDURE

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

Subjects at risk for NAFLD
Fibro ScanPROCEDURE

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

Subjects at risk for NAFLD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Olmsted County residents at the time of search
  • Age 18 or older
  • No personal history of NAFLD diagnosis (administrative codes)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Elasticity Imaging TechniquesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • ALINA M ALLEN, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodie A Cogswell

CONTACT

507-266-3995cogswell.jodie@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 28, 2020

Study Start

October 10, 2020

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)