Integrated Multi-omics Data for Personalized Treatment of Obesity-associated Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body mass index greater or equal to 40 kg/m².
Body mass index between 35 and 40 kg/m² 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.
Disqualifiers
Legal or illegal drug consumption, including alcohol.
Diagnosis of Hepatitis.
Current cancer diagnosis or treatment.
Clinical or analytical evidence of severe illness.
Trial population
Participants are consecutive patients with obesity type II or III attending the bariatric surgery unit for treatment. In this center, women are more frequent than men. The average age is 49 (interquartile range 41 - 58). Steatohepatitis (\~30 percent), type 2 diabetes mellitus (\~40 percent), hypertension (\~60 percent), and dyslipidemia (\~35 percent) are the most prevalent comorbidities. Other common ailments are obstructive sleep apnea (\~20 percent) and hypothyroidism (\~10 percent).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
To propose diagnostic tests for liver diseases before surgical decisions.
Diagnostic testObservational although patients are candidates for metabolic surgery.
Treatment groups
1,104 Participants
are divided into 3 treatment groupsGroup A: Severe obesity without liver disease1 intervention
Group B: Severe obesity with liver disease without criteria for steatohepatitis1 intervention
Group C: Severe obesity with well-defined steatohepatitis and/or cirrhosis1 intervention
Trial outcomes
Primary outcomes
1
Weight change
The effect of bariatric surgery on adiposity outcomes.
Time frame
1 to 10 years2
Type 2 diabetes mellitus incidence
The effect of bariatric surgery on metabolic outcomes.
Time frame
1 to 10 years3
Hypertension incidence
The effect of bariatric surgery on metabolic outcomes.
Time frame
1 to 10 years4
Chronic liver diseases incidence
The usefulness of imaging techniques on metabolic outcomes.
Time frame
1 to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Investigacio Sanitaria Pere Virgili
Lead sponsor
Hospital Universitari Sant Joan
Collaborator
La Caixa Foundation
Collaborator
Instituto de Salud Carlos III
Collaborator
University of Barcelona
Collaborator
Source ClinicalTrials.gov