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

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05050721
• Other study ID #: 043.HEP.2019.D
• Status: Withdrawn
• Start date: October 4, 2019
• Est. completion date: September 10, 2021

Study information

• Verified date: December 2021
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 10, 2021
• Est. primary completion date: August 10, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis (NASH)

Intervention

Other:
• CT imaging
clinical, radiological and biochemical parameters associated with disease progression

Locations

Country	Name	City	State
United States	The Liver Institute at Methodist Dallas Medical Center	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factor (Age)	Age will be measured in years	1 year
Primary	Risk factor (BMI)	Weight and height will be measured to determine BMI. it will be measured in kg/m^2.	1 year