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

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis

• Registration Number: NCT05357352
• Lead Sponsor: Methodist Health System

Brief 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.

Study Timeline

• Study Start: 2019-05-24
• Primary Completion: 2021-04-07
• Study Completion: 2021-04-07
• Study First Submitted: 2021-11-09
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-27
• Last Update Submitted: 2022-04-27
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• Patients identified to have biopsy-proven NASH within April 2013 - June 2020
• Minimum age 18, no upper limit of age
• Patients with complete records

Exclusion Criteria

• Age <18 years
• Incomplete records
• Diseases other than NASH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NAS score lover	April 2013 - June 2020	Severity of Nonalcoholic fatty liver disease and fibrosis staging. The NAS is a measure of grade and is the sum of numerical scores applied to steatosis (0-3), hepatocellular ballooning (0-2), and lobular inflammation (0-3). Accordingly, the NAS ranges from 0 to 8 (see Table 12.3). The NAS is one of the few grading systems for NAFLD that has been externally validated.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States