Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-04

Study Completion Date

2021-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States. Although the majority of patients with NAFLD have a benign clinical course, the development of non-alcoholic steatohepatitis (NASH ), with necro-inflammation and progressive fibrosis, increases the risk for development of cirrhosis and its complications. Among patients with NASH, approximately 28% develop cirrhosis over an 8-year follow-up period. NASH and advanced fibrosis is associated with increased morbidity and mortality among those patients with advanced histologic severity such as NASH and fibrosis the gold standard for diagnosing and staging NAFLD is liver biopsy. Liver biopsy is associated with costs and risks that make it impractical for generalized use in a condition that affects such a high portion of the population. Furthermore, liver biopsy is also limited by significant sampling error in NAFLD. Thus, there is a pressing need for accurate non-invasive predictors of NAFLD that would also allow differentiation of those subjects at higher risk of disease progression. At present, in the clinical setting, some demographic factors, blood tests, and imaging studies can be used to predict a higher risk of disease in patients being evaluated for NAFLD. These predictors, however, are of limited sensitivity and specificity compared with liver biopsy. The development and validation of accurate predictors and scoring systems to identify patients at higher risk for NASH and fibrosis would allow identification of subjects who would benefit the most from liver biopsy and potentially help monitor disease

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is a retrospective chart review study. All Methodist Dallas Medical Center (MDMC) patients with fatty liver diseases meeting the inclusion and exclusion criteria as mentioned below will be included in the study. Charts from Jan 2000 - Jan 2019 will be reviewed for data collection.

Data variables: age, weight, Height , BMI, gender, AST, ALT, Bilirubin, albumin, Alkaline phosphatase, WBC, PLT, Hb, sodium, potassium, creatinine, ferritin, insulin, glucose , HDL, LDL,VLDL, cholesterol, triglyceride. CT imaging, ultrasound findings, fibroscan, MR-Elastrography, liver biopsy results, presence of comorbidities like diabetes, hypertension and dyslipidemia

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-alcoholic Steatohepatitis (NASH)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic liver disease, steatosis, inflammation, fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT imaging

clinical, radiological and biochemical parameters associated with disease progression

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ultrasound, fibroscan, MR-Elastrography, liver biopsy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients both male and female greater than 18 years with radiologic or histologic evidence of fatty liver will be included in the study.

Exclusion Criteria

* Patients with history of fatty liver less than 18 years of age.
* Patient's with fatty liver consuming alcohol up to greater than one drink per day.
* All fatty liver patients with other chronic liver disease such as hepatitis B, hepatitis C, primary biliary cirrhosis, primary biliary cholangitis, autoimmune hepatitis, alpha one antitrypsin disease or Wilsons disease superimposed on fatty liver disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mangesh Pagadala, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Liver Institute at Methodist Dallas Medical Center

Irving, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

043.HEP.2019.D

Identifier Type: -

Identifier Source: org_study_id