Integrated Multi-omics Data for Personalized Treatment of Obesity-associated Fatty Liver Disease
Integrated Multi-omics and Machine Learning-driven Personalized Treatment of Obesity-associated Fatty Liver Disease
2 other identifiers
observational
1,104
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2008
CompletedFirst Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 13, 2024
November 1, 2024
20.5 years
September 21, 2022
November 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Weight change
The effect of bariatric surgery on adiposity outcomes.
1 to 10 years
Type 2 diabetes mellitus incidence
The effect of bariatric surgery on metabolic outcomes.
1 to 10 years
Hypertension incidence
The effect of bariatric surgery on metabolic outcomes.
1 to 10 years
Chronic liver diseases incidence
The usefulness of imaging techniques on metabolic outcomes.
1 to 10 years
Dyslipidemia incidence
The effect of bariatric surgery on metabolic outcomes.
1 to 10 years
Study Arms (3)
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).
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).
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).
Interventions
Observational although patients are candidates for metabolic surgery.
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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 chronic or acute inflammation.
- Clinical or analytical evidence of infectious diseases.
- Clinical or analytical evidence of terminal illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Investigacio Sanitaria Pere Virgililead
- Hospital Universitari Sant Joancollaborator
- La Caixa Foundationcollaborator
- Instituto de Salud Carlos IIIcollaborator
- University of Barcelonacollaborator
Study Sites (1)
Hospital Universitari Sant Joan
Reus, Tarragona, 43204, Spain
Related Publications (1)
Jimenez-Franco A, Castane H, Martinez-Navidad C, Placed-Gallego C, Hernandez-Aguilera A, Fernandez-Arroyo S, Samarra I, Canela-Capdevila M, Arenas M, Zorzano A, Hernandez-Alvarez MI, Castillo DD, Paris M, Menendez JA, Camps J, Joven J. Metabolic adaptations in severe obesity: Insights from circulating oxylipins before and after weight loss. Clin Nutr. 2024 Jan;43(1):246-258. doi: 10.1016/j.clnu.2023.12.002. Epub 2023 Dec 6.
PMID: 38101315DERIVED
Biospecimen
Serum, plasma, hepatic, subcutaneous and visceral adipose tissues.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Joven, Professor
Institut Investigacio Sanitaria Pere Virgili
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine at the Rovira i Virgili University
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 26, 2022
Study Start
June 25, 2008
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
November 13, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Once decided the repository web address.
- Access Criteria
- Decided by the principal investigator.
The Data Management Plan makes data fully findable, accessible, interoperable, and reusable, following the indication of the Horizon 2020 initiative of the European Union. The clinical team identified sensitive data, including epidemiological, anthropometric, and medical information. It is the only responsibility of the principal investigator to ensure that sensitive data are de-identified, implementing technical safeguards to guarantee anonymity. Most data will be experimental and obtained from the analysis of column value and data format description (.txt or .csv) and syntax scripts (.R). The external collaborators, especially those involved in validation cohorts, may have access to data upon request. With the acceptance of the principal investigator, Rovira i Virgili University's institutional service will guarantee digital access to repositories with raw data generated in research analyses.