Understanding and reducing late diagnosis of alcohol-related diseases and metabolic liver disease.
Study of the Drivers of Late Diagnosis of Alcohol Related Diseases, Alone or in Combination With Metabolic Dysfunconal Associated Fatty Liver Disease, Implementation and Evaluation of Itnerventions to Reduce Its Burden.
This study is trying to find ways to help people over 30 with signs of liver problems related to alcohol use and fatty liver disease get diagnosed earlier and receive better treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Trial ID | NCT06403332 on ClinicalTrials.gov |
What this trial studies
This study investigates the factors contributing to the late diagnosis of alcohol-related liver disease (ALD) and metabolic dysfunction associated fatty liver disease (MAFLD). It aims to implement and evaluate brief interventions to reduce the burden of these conditions, which are exacerbated by social determinants of health and stigma. The study focuses on patients over 30 years old who show signs of alcohol use disorder and liver abnormalities but have not yet experienced decompensated liver disease. By addressing these issues, the study seeks to improve early diagnosis and treatment outcomes for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 30 with suspected alcohol use disorder and liver abnormalities who have not experienced decompensated liver disease.
Not a fit: Patients with a history of decompensated advanced liver disease or severe extrahepatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of alcohol-related and metabolic liver diseases, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown success in addressing alcohol-related diseases through early intervention and education, suggesting that this approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Never decompensated patients with ArLD suspicion * Age over 30 * Diagnosis of AUD identified by the AUDIT test or excessive alcohol consumption, i.e., suspicion of current or recent (within one year) AUD or persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/or alcohol-induced organ involvement other than decompensated liver disease * Alanine (ALT) and aspartate aminotransferases (AST) \<5 times upper normal limit * Bilirubin \<3 mg/dL or/and * AST/ALT ratio \>1.5 or/and * GGT \>100 mg/dL • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC * Patients with severe extrahepatic disease or terminal illness Young patients with risk alcohol intake and without liver disease * Age between 18-30 years * Diagnosis of AUD identified by the AUDIT test or for whom there is a high suspicion of current or recent (within one year) AUD or persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam and/or alcohol-induced organ involvement other than decompensated liver disease * Normal liver test including AST, ALT, bilirubin and GGT. • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC * Patients with severe extrahepatic disease or terminal illness Previously or currently decompensated patients • Age over 30 * Diagnosed ALD with a current or previous liver-related decompensation (i.e., ascites or edemas, hepatic encephalopathy, hepatocellular carcinoma, upper gastrointestinal bleeding, spontaneous bacterial peritonitis or alcoholic hepatitis) • Terminal illness with less than 6 months live expectancy (except advanced hepatocellular carcinoma) * Previous liver transplant recipient Patients without significant liver disease * Age over 30 * Alcohol intake of \<10g per day without current or previous AUD or heavy alcohol intake • Significant liver pathology MASLD patients with a maximum alcohol intake of 20g per day. * Age over 30 * Alcohol intake (\<20g/day in women and \<30g/day in men), * Patients with obesity and/or diabetes mellitus type 2 and/or metabolic syndrome defined by the presence of two or more of the Eslam et al. criteria. • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC * Patients with severe extrahepatic disease or terminal illness
Where this trial is running
Barcelona and 1 other locations
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- University Hospital Vall d'Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Portollano
- Email: cristina.portellano@vhir.org
- Phone: 634 832 759
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.