Clinical trial NCT05357352: Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis
Official title: Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Keywords: NASH
NAFLD
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed NAFLD/NASH via liver biopsy from the patient database from the Methodist Liver Institute from April 2013 - June 2020.

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.

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

Primary outcomes:
measure: NAS score lover
timeFrame: April 2013 - June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Liver Institute at Methodist Dallas Medical Center
name: Mantry Parvez, MD
role: PRINCIPAL_INVESTIGATOR
References: