Actively Recruiting
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.
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-05-07
350
Participants Needed
2
Research Sites
96 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari Vall d'Hebron Research Institute
Lead Sponsor
U
Universitat Pompeu Fabra
Collaborating Sponsor
AI-Summary
What this Trial Is About
Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. ALD is the main cause of cirrhosis globally and is responsible for 60% of cirrhosis in Europe and North America. Importantly, another etiology of liver disease is on the rise due to the epidemics of obesity and diabetes mellitus in Western countries, i.e., metabolic dysfunction associated fatty liver disease (MAFLD). ALD and MAFLD are largely shaped by social determinants of health (SDH) and lead to mounting health inequalities. Moreover, ALD is subject to strong stigmatization, particularly amongst women, which often leads to lack of inquiry by health professionals. Alone or in combination (MAFLD-OH), both diseases represent a challenge for epidemiologists, clinicians and policy makers in charge of health systems' organization. One of the hurdles to reduce the burden of ALD is the lack of early detection of asymptomatic liver disease among patients with alcohol use disorder (AUD) and heavy drinkers. The only measure that has been proven effective in any phase of the disease is to either stop, compensate, or reverse the liver disease progression, is alcohol abstinence. We hypothesize that establishing effective screening programs to identify patients with ALD and related disorders, coupled with effective treatment will lead to more positive outcomes in prognosis. The central aim of the StopALD Project is to identify patients with advanced ALD during the asymptomatic phases of the disease, as well as identifying the factors related with the lack of early detection to better implement interventions so to tackle both the lack of early detection of ALD and heavy drinking patterns among young people before ALD occurs.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Never decompensated patients suspected of alcohol-related liver disease aged over 30
- Diagnosis or suspicion of alcohol use disorder with recent or persistent heavy alcohol intake
- Liver enzyme levels ALT and AST less than 5 times the upper normal limit
- Bilirubin less than 3 mg/dL or AST/ALT ratio greater than 1.5 or GGT over 100 mg/dL
- Young patients aged 18-30 with high suspicion of alcohol use disorder and normal liver tests
- Previously or currently decompensated patients over 30 diagnosed with alcohol-related liver disease and liver-related complications
- Patients without significant liver disease aged over 30 with low alcohol intake and metabolic conditions
- Patients with obesity, type 2 diabetes, or metabolic syndrome with limited alcohol intake
You will not qualify if you...
- Patients with a past history of decompensated advanced liver disease or known hepatocellular carcinoma
- Patients with severe extrahepatic disease or terminal illness
- Previous liver transplant recipients
- Terminal illness with less than 6 months life expectancy (except advanced hepatocellular carcinoma)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
2
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
P
Portollano
CONTACT
S
Sala
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
7
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