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. (StopALD)

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: Metabolic and Alcohol Related/Associated Liver Disease; Alcohol-related Liver Disease; Alcohol Use Disorder; Metabolic Disfunction Associated Steatotic Liver Disease

Treatments: Behavioral: brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06403332

PR(AG)30/2023

Details and patient eligibility

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 7 patient groups

Cohort A intervention

Experimental group

Treatment:

Behavioral: brief intervention

Cohort A non intervention

No Intervention group

Cohort B intervention

Experimental group

Treatment:

Behavioral: brief intervention

Cohort B no intervention

No Intervention group

Control grup no significant liver disease

No Intervention group

Control group MASLD

No Intervention group

Control group decompensated ArLD

No Intervention group