NCT05357352

Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Few studies have evaluated an extensive list of possible risk factors for NAFLD for their association with presence and severity of histologic features. We wish to conduct a retrospective study on these possible factors (including demographics, comorbid diseases, and medications) for their association, if any, with severity of histopathologic findings. This study hypothesize that certain risk factors, specifically those contributing to or consisting of metabolic syndrome, will have higher NASH Fibrosis stages.

Detailed description

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in Western countries, and is projected to become one of the foremost indications for liver transplantation (2). Both NAFLD and its most severe histopathologic subtype, non-alcoholic steatohepatitis (NASH) can progress to cirrhosis and its complications including hepatic malignancy, and are thus an important target for study. It is well-known that several risk factors are associated with the development of NAFLD, including obesity, type 2 diabetes mellitus, and metabolic syndrome (1), however their association with the presence and severity of histologic features of NAFLD/NASH has not been extensively examined. This study can help determine prognostic indicators for NALFD/NASH which can be useful in its prevention and treatment. This is a retrospective chart review and de-identified data analysis. Data will be extracted from the patient database from the Methodist Liver Institute from April 2013 - June 2020. Patients with confirmed NAFLD/NASH via liver biopsy will be selected and NAFLD Activity Score and Fibrosis stage will be assessed. Data will then be collected on demographics, comorbid diseases, and medications from EPIC EMR system used by Methodist Health System.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
OTHER	NAFLD/NASH	the characteristics of patients with advanced fibrosis in a community-based referral center.

Timeline

• Start date: 2019-05-24
• Primary completion: 2021-04-07
• Completion: 2021-04-07
• First posted: 2022-05-02
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States