Using lab and computer analysis to understand fatty liver disease linked to obesity
Studies patient samples with computer models to understand obesity-related fatty liver disease.
Key facts
- Who runs it
- Institut Investigacio Sanitaria Pere Virgili
- Where
- Reus, SpainSee the site
- Trial code
- Registry title
- Integrated Multi-omics Data for Personalized Treatment of Obesity-associated Fatty Liver Disease
- Status
- Recruiting
- People taking part
- 1,104 people, planned
- Started
- 25 Jun 2008
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 3 groups
- Treatments tested
- To propose diagnostic tests for liver diseases before surgical decisions.
- Record updated
- 13 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity who may also have fatty liver disease. Their samples and health data will be studied to build computer models.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Body mass index of 40 kg/m^2 or more, or between 35 and 40 kg/m^2 with high-risk conditions (high blood pressure, high blood fats, or type 2 diabetes)
Main reasons for not taking part
- Use of legal or illegal drugs, including alcohol
- Diagnosis of hepatitis
- Current cancer diagnosis or treatment
- Severe, terminal or infectious illness
- Chronic or acute inflammation
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Body mass index greater or equal to 40 kg/m\^2
- Body mass index between 35 and 40 kg/m\^2 with high-risk comorbidities (diagnosis or treatment for hypertension, dyslipidemia, or type 2 diabetes mellitus)
- Positive psychiatric evaluation
- Age greater or equal to 18 years old
Who cannot take part
- Legal or illegal drug consumption, including alcohol
- Diagnosis of Hepatitis
- Current cancer diagnosis or treatment
- Clinical or analytical evidence of severe illness
- Clinical or analytical evidence of infectious diseases
- Clinical or analytical evidence of terminal illness
- Clinical or analytical evidence of chronic or acute inflammation
Where in Spain
- Hospital Universitari Sant JoanReus, SpainContact: Jorge Joven, ProfessorTaking people
About the trial
What the trial wants to find out
The investigators seek to analyze the samples provided by patients with obesity-associated fatty liver disease at the multi-omics level and to integrate the results with clinical information, genotypic variants, and factors influencing inter-organ crosstalk. The main aim is to improve the interpretation of fatty liver disease associated with obesity and diabetes by developing predictive models built with algorithms from artificial intelligence. The challenge is to decipher the flow of information by exploring contributing factors, proximate causes of regulatory defects, and maladaptive responses that may promote therapeutic approaches.
The 3 groups in the trial
- Severe obesity without liver disease
Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 0-2).
Treatment: To propose diagnostic tests for liver diseases before surgical decisions.
- Severe obesity with liver disease without criteria for steatohepatitis
Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis, but their biopsies presented some liver severity (scores 3 and 4).
Treatment: To propose diagnostic tests for liver diseases before surgical decisions.
- Severe obesity with well-defined steatohepatitis and/or cirrhosis
Patients with severe obesity who met the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 5-8).
Treatment: To propose diagnostic tests for liver diseases before surgical decisions.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Integrated Multi-omics and Machine Learning-driven Personalized Treatment of Obesity-associated Fatty Liver Disease
- Plain-language title
- Using lab and computer analysis to understand fatty liver disease linked to obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 November 2024