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

NCT ID: NCT05357352

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 263 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2021-04-07

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

NAFLD/NASH

the characteristics of patients with advanced fibrosis in a community-based referral center.

Intervention Type: OTHER

Other Intervention Names

characteristics of patients

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mantry Parvez, MD

Role: PRINCIPAL_INVESTIGATOR

The Liver Institute at Methodist Dallas Medical Center

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

002.HEP.2019.D

Identifier Type: -

Identifier Source: org_study_id