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

NCT05050721 | Withdrawn

• 1 other identifier: 043.HEP.2019.D
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Non-alcoholic Steatohepatitis (NASH)

Keywords

Chronic liver disease, steatosis, inflammation, fibrosis

Outcome Measures

Primary Outcomes (2)

• Risk factor (Age)

  Age will be measured in years

  1 year

• Risk factor (BMI)

  Weight and height will be measured to determine BMI. it will be measured in kg/m\^2.

  1 year

Interventions

CT imaging OTHER

clinical, radiological and biochemical parameters associated with disease progression

Also known as: ultrasound, fibroscan, MR-Elastrography, liver biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

The Liver Institute at Methodist Dallas Medical Center

Irving, Texas, 75603, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Inflammation; Fibrosis

Interventions

Postmortem Imaging; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mangesh Pagadala, M.D.

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 20, 2021
• Study Start: October 4, 2019
• Primary Completion: August 10, 2021
• Study Completion: September 10, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

US (1)