Establishing a cohort for non-alcoholic fatty liver disease and developing fibrosis markers
Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
This study is trying to gather information from people with non-alcoholic fatty liver disease to see if they can find signs that predict how the disease might worsen over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Boramae Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02206841 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a cohort of patients with non-alcoholic fatty liver disease (NAFLD) to develop markers that can predict the histologic progression of liver fibrosis. The methodology includes various assessments such as acoustic radiation force impulse elastography, transient elastography, liver biopsies, and body composition analysis. Additionally, the study will evaluate pulmonary function, cardiovascular health, and conduct brain imaging and gastrointestinal assessments. The goal is to gather comprehensive data that can lead to better understanding and management of liver fibrosis in NAFLD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically or radiologically confirmed non-alcoholic fatty liver disease.
Not a fit: Patients with significant alcohol consumption, viral hepatitis, autoimmune hepatitis, or other metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting liver fibrosis progression, allowing for earlier interventions in patients with NAFLD.
How similar studies have performed: Other studies have shown promise in developing fibrosis markers for liver diseases, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed fatty liver disease * Patients with radiologically confirmed fatty liver disease Exclusion Criteria: * History of significant alcohol consumption * Viral hepatitis * Autoimmune hepatitis * Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency) * Hepatotoxic medication (e.g. amiodarone)
Where this trial is running
Seoul
- Seoul Metropolitan Government Seoul National University — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Won Kim, Professor — SMG-SNU Boramae Medical Center
- Study coordinator: Won Kim, MD,PhD
- Email: drwon1@snu.ac.kr
- Phone: 8228702233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.