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NCT03142867 · ClinicalTrials.gov registry record
The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Adults
A clinical trial, sponsored by The Geneva Foundation.
- Terminated
- Registry status
- 826
- Enrollment target
NCT03142867: Clinical Trial study, sponsored by The Geneva Foundation.
NCT03142867 is a clinical trial that was terminated before completion, run by The Geneva Foundation. The registered enrollment target is 826 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03142867 was terminated before completion, sponsored by The Geneva Foundation.
- TERMINATED
- Registry status
- 826 participants
- Enrollment target
Study Summary
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 abdo
Primary Outcome
Determine the prevalence of NAFLD in military beneficiaries between ages 18 to 80. This will be determined by the % of subjects determined to have NAFLD via liver biopsy.
Interventions
- OTHER non-applicable
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 826 participants |
| Start Date | 2015-08-25 |
| Est. Completion | 2019-06-27 |
Why NCT03142867 stopped before completion
NCT03142867 is an observational study that tracks outcomes without assigning an intervention. The registered 826 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which non-applicable is the first listed.
NCT03142867 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03142867 about?
NCT03142867 is a clinical study titled "The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Adults". 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. H...
What is the current status of trial NCT03142867?
This trial is currently terminated. The enrollment target is 826 participants. The study started on 2015-08-25. Estimated completion is 2019-06-27.
What interventions are being tested in trial NCT03142867?
The interventions under investigation include: non-applicable (OTHER).
Who is sponsoring clinical trial NCT03142867?
This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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