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

NCT05357352 | Completed

• 1 other identifier: 002.HEP.2019.D
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease

Keywords

NASH; NAFLD

Outcome Measures

Primary Outcomes (1)

• NAS score lover

  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.

  April 2013 - June 2020

Interventions

NAFLD/NASH OTHER

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

Also known as: characteristics of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Mantry Parvez, MD

  The Liver Institute at Methodist Dallas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: May 2, 2022
• Study Start: May 24, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: March 23, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)