Assessing the prevalence of Non-Alcoholic Fatty Liver Disease in adults
The Olmsted NAFLD Epidemiology Study (TONES)
This study is trying to find out how common Non-Alcoholic Fatty Liver Disease is among adults in Olmsted County, Minnesota, to help improve early diagnosis and treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04365855 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) within a population. Researchers will enroll a random sample of adults from Olmsted County, Minnesota, to create a well-characterized cohort for validating diagnostic models and determining long-term outcomes. The study employs various interventions, including Magnetic Resonance Elastography and liver biopsies, to gather comprehensive data on liver health. The ultimate goal is to develop effective screening strategies for early diagnosis and intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older residing in Olmsted County with no prior diagnosis of NAFLD.
Not a fit: Patients with a history of excessive alcohol consumption or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment options for patients with liver disease.
How similar studies have performed: Other studies have shown success in using machine learning models for diagnosing liver diseases, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Alina M Allen, Md — Mayo Clinic
- Study coordinator: Jodie A Cogswell
- Email: cogswell.jodie@mayo.edu
- Phone: 507-266-3995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.