NAFLD Clinical Trial
Official title:
The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology
Background: During the hepatology evaluation, vibration-controlled transient elastography (VCTE) is often used as a clinical decision aid to target high-risk patients for liver biopsy. The enhanced liver fibrosis (ELF) test is expected to be approved in the US. We tested the hypothesis that making the ELF results available to the treating hepatologist will result in more appropriate and targeted use of liver biopsy in patients with elevated liver enzymes or fatty liver, and will result in more cases of advanced fibrosis/cirrhosis being diagnosed. Methods: During the hepatology evaluation for elevated liver enzymes or fatty liver at the University of Kansas Medical Center, the hepatologists (8 total) make a clinical decision on whether patients shall receive VCTE. At the end of the clinic visit, patients were enrolled and randomized to receiving an ELF test. Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. The primary outcome is the rate of a diagnosis of F3-4 fibrosis based on liver biopsy or clinical diagnosis of cirrhosis with the initiation of hepatocellular carcinoma surveillance. Four hundred fifty patients are to be enrolled over two years.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06101433 -
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
|
N/A | |
| Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
| Recruiting |
NCT05479721 -
LITMUS Imaging Study
|
||
| Completed |
NCT05527938 -
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
|
N/A | |
| Recruiting |
NCT06308757 -
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
|
N/A | |
| Completed |
NCT02654977 -
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
|
Phase 2 | |
| Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
| Recruiting |
NCT06047847 -
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
|
N/A | |
| Active, not recruiting |
NCT03534908 -
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
|
||
| Recruiting |
NCT06098417 -
Biomarkers in the Diagnosis and Prognosis of NAFLD
|
||
| Recruiting |
NCT04564391 -
Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins
|
N/A | |
| Not yet recruiting |
NCT05984745 -
Effect of CoQ10 on the Outcome of MAFLD Patients
|
Phase 2 | |
| Not yet recruiting |
NCT05052515 -
The Effects of Natural Extracts Supplementation on NASH Patients
|
N/A | |
| Recruiting |
NCT02459496 -
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
|
N/A | |
| Completed |
NCT01936779 -
Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans
|
N/A | |
| Completed |
NCT05844137 -
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
|
N/A | |
| Recruiting |
NCT04664036 -
Prevalence, Incidence and Characteristics of NAFLD/NASH in Type 1 Diabetes Mellitus
|
||
| Recruiting |
NCT04976283 -
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
|
Phase 4 | |
| Recruiting |
NCT03587298 -
Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
|
||
| Completed |
NCT02952170 -
Impact of Weight Loss Surgery in Adolescents With NAFLD
|
N/A |