Non-Alcoholic Fatty Liver DiseaseNCT05357352
Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Steatohepatitis, run by Methodist Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis
- What is being tested?
- NAFLD/NASH
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 7 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed NAFLD/NASH via liver biopsy from the patient database from the Methodist Liver Institute from April 2013 - June 2020.
Who may be able to join
- Patients identified to have biopsy-proven NASH within April 2013 - June 2020
- Minimum age 18, no upper limit of age
- Patients with complete records
Who cannot join
- Age <18 years
- Incomplete records
- Diseases other than NASH
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
Read the 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.
- Being tested
- NAFLD/NASH
- Keywords
- NASH, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFLD/NASHOther
Also called characteristics of patients
the characteristics of patients with advanced fibrosis in a community-based referral center.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2013 - June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start24 May 2019
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mantry Parvez, MD, Principal investigator, The Liver Institute at Methodist Dallas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357352
- Sponsor's protocol ID
- 002.HEP.2019.D
- Status last verified
- Apr 2022
- First submitted
- 9 Nov 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis
- ClinicalTrials.gov ID
- NCT05357352
- Acronym / sponsor ID
- 002.HEP.2019.D
- Keywords
- NASH, NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed NAFLD/NASH via liver biopsy from the patient database from the Methodist Liver Institute from April 2013 - June 2020.
Key inclusion criteria (3 listed)
- Patients identified to have biopsy-proven NASH within April 2013 - June 2020
- Minimum age 18, no upper limit of age
- Patients with complete records
Key exclusion criteria (3 listed)
- Age <18 years
- Incomplete records
- Diseases other than NASH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAFLD/NASHAlso: characteristics of patientsthe characteristics of patients with advanced fibrosis in a community-based referral center. | Other | – |
Primary outcome
NAS score lover
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mantry Parvez, MD principal investigator
The Liver Institute at Methodist Dallas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Steatohepatitis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAS score lover (time frame: April 2013 - June 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.