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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
University Hospital Vall d'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Portollano
cristina.portellano@vhir.org
634 832 759
Backup
Sala
gestio.projectes@vhir.org
634 833 106
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2024-12-06
Participants
Target number of participants: 350
Treatments
Experimental: Cohort A intervention
No_intervention: Cohort A non intervention
Experimental: Cohort B intervention
No_intervention: Cohort B no intervention
No_intervention: Control grup no significant liver disease
No_intervention: Control group MASLD
No_intervention: Control group decompensated ArLD
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: Universitat Pompeu Fabra, IDIAPJgol

This content was sourced from clinicaltrials.gov