The Olmsted NAFLD Epidemiology Study (TONES)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Alcoholic Fatty Liver Disease
- Non Alcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: We will send survey letters to 3,000 adult Olmsted County residents with research authorization, identified based on a random search of the REP database. We anticipate a 33% response rate. Therefore we plan to accrue 1,000 participants. Based on literature estimates, approximately 600/1000 adults will be at risk for NAFLD due to overweight/obese status. This large sample size will be sufficient to derive crucial epidemiologic data of prevalence, natural history and risk factors for long-term complications in the community.Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (1) (2). Epidemiologic studies assessing the prevalence of NAFLD in the general population have been largely based on NHANES surveys between 1988 and 199...
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 (1) (2). Epidemiologic studies assessing the prevalence of NAFLD in the general population have been largely based on NHANES surveys between 1988 and 1992 (3), or single center hepatology evaluation, which is limited by selection bias. Obesity rates have increased significantly since early 1990s (4), therefore the prevalence of NAFLD has likely changed. 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. 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.
Tracking Information
- NCT #
- NCT04365855
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: ALINA M ALLEN, MD Mayo Clinic