Clinical trial NCT05050721: Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
Official title: Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-alcoholic Steatohepatitis (NASH)
Keywords: Chronic liver disease, steatosis, inflammation, fibrosis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic liver disease registry and EPIC at liver institute and MDMC. All patients meeting the inclusion criteria will be included for the retrospective chart based study from Jan 2000 - Jan 2019.

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Risk factor (Age)
timeFrame: 1 year
measure: Risk factor (BMI)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Irving
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Mangesh Pagadala, M.D.
role: PRINCIPAL_INVESTIGATOR
References: