NCT03142867: PREV

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Adults

Terminated Last updated 24 February 2023

What this trial tests

trial testing non-applicable in Non-Alcoholic Fatty Liver Disease in 826 participants. Terminated before completion.

Timeline

25 August 2015

Primary endpoint
27 June 2019

27 June 2019

Quick facts

Lead sponsor	The Geneva Foundation
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	826
Start date	25 August 2015
Primary completion	27 June 2019
Estimated completion	27 June 2019
Sites	1 location across United States

Drugs / interventions tested

• non-applicable

Conditions studied

• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
• Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →

Sponsor

The Geneva Foundation

Who can join

Adults 18 to 80, any sex, with Non-Alcoholic Fatty Liver Disease or Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nonalcoholic fatty liver disease (NAFLD) is a global health concern with a suspected increasing prevalence due to the rise in obesity and diabetes mellitus. The vast majority of patients will have isolated steatosis or steatosis with mild inflammation that is very unlikely to progress in severity. However, about 25% of patients with NAFLD have non-alcoholic steatohepatitis (NASH), the more aggressive form of the disease that is associated with fibrosis progression and potential risk for cirrhosis and end-stage liver disease complications. Additionally, multiple studies have demonstrated an association between NAFLD and the presence of coronary artery disease by either coronary CT angiography (CCTA) or coronary artery calcium (CAC) score. Cardiovascular disease is the most important cause of mortality in patients with the entire spectrum of NAFLD. In the era of advanced imaging and functional vascular assessment it is possible that novel risk assessments are poised to refine overall prognostic estimation in this population. Multiple analyses have suggested that NAFLD is an independent and strong predictor of significant CAD independent of cardiovascular risk factors, including a significant burden of high risk CCTA findings in one analysis of symptomatic patients in the emergency department. Given the multiple metabolic derangements inherent in the NAFLD population, endothelial dysfunction is also an important contributor to global cardiovascular dysfunction. Furthermore, data suggests that patients with NAFLD may be at increased risk of adenomatous polyp formation and colorectal adenocarcinoma. In addition, it is suboptimal to require a liver biopsy to diagnose NASH. Recent imaging advances have made it possible to assess liver fibrosis but have yet to be fully studied in NAFLD. The purpose of this study is to assess the current prevalence and severity of NAFLD in adult subjects. Secondary endpoints include correlation to new vascular function (cine scan of the abdominal aorta) and echocardiographic imaging modalities available at BAMC and to circulating biomarker panels as well as to determine the prevalence and severity of CAD by multidetector coronary CT angiography with subject outcomes being monitored prospectively. Additionally, correlation of NAFLD diagnosis to colonoscopy findings will be performed.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Correlations Between MRI Biomarkers PDFF and cT1 With Histopathological Features of Non-Alcoholic Steatohepatitis.
   Dennis A, Kelly MD, Fernandes C, Mouchti S, et al · · 2020 · cited 75× · PMID 33584535 · DOI 10.3389/fendo.2020.575843
2. Enhancing liver fibrosis measurement: Deep learning and uncertainty analysis across multi-center cohorts.
   Wojciechowska M, Malacrino S, Windell D, Culver EL, et al · · 2026 · PMID 42023068 · DOI 10.1016/j.jpi.2026.100653