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Recruiting NCT05712603

The Nijmegen-Leiden-Amsterdam 2-tiered Care Path Study

Conditions: Non-Alcoholic Fatty Liver Disease

Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Location: Netherlands

Summary

Non-alcoholic fatty liver disease (NAFLD) is a liver disease, caused by storage of fat in the liver. The most-important risk-factors are being overweight, and disorders in sugar and cholesterol handling of the body. On average does around 30% of the population worldwide have any signs of fatty liver. Most people will not get severe complaints as a result of their fatty liver. But in some of them, the fat storage will lead to hepatitis. This causes damage to the liver which can eventually lead to scarring of the liver, and in some patients to cirrhosis. This possibly can cause liver failure, liver cancer, an several complaints which reduce the quality of life. There are several tests which can help in detecting scarring of the liver. However, the scientific world still does not know well enough which test works best and if they perhaps might work better if they are used together. In this study these questions will be investigated in order to design a care path which does several tests consecutively. The goal is that this will make it possible to easily detect a severely diseased liver and that this will eventually help to detect patients earlier so they can be treated earlier and complications of the disease might be reduced. Moreover, is the goal that this study will lead to a decrease in unnecessary referrals to a hepatologist, resulting in a reduction in invasive diagnostic interventions. Hospital specialists who think that their patient might be at risk for advanced liver disease, can refer a patient to this study. Participants will go to the hospital for one study visit where several tests will be done which are designed to detect liver scarring. Depending on the results, a participant will be referred to a hepatologist for more extensive diagnostics or referred back to the referring specialist with advice for management of the disease.

Eligibility Criteria

Inclusion Criteria:Age ≥ 18 years;Suspected by treating physician to suffer from a severe stage of NAFLD-fibrosis.Exclusion Criteria:Previous diagnosis of advanced (≥F3) liver fibrosis;Any other known chronic liver disease (alcoholic steatohepatitis, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1-antitrypsin deficiency);Drugs that may cause drug-induced hepatic steatosis, (table provided elsewhere)Present excessive alcohol use, defined as > 2 units/day for women and > 3 units/day for men;A psychiatric, addictive or any other disorder that compromises the subject's ability to understand the study content and to give written informed consent for the participation in the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05712603). StuddyBuddy aggregates publicly available trial information.