Sponsor study identifier
Secondary identifiers
OTHER · Hospital Universitari Sant Joan
observational
1,104
1 country
1
Study Start
June 25, 2008
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2008
Actual (reported)September 21, 2022
Actual (reported)September 26, 2022
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patients with severe obesity who did not meet the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 0-2).
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).
Patients with severe obesity who met the criteria described in Kleiner et al. (2005) for nonalcoholic steatohepatitis diagnosis (score 5-8).
Observational although patients are candidates for metabolic surgery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Hospital Universitari Sant Joan
Reus, Tarragona, 43204, Spain
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.
Serum, plasma, hepatic, subcutaneous and visceral adipose tissues.
Jorge Joven, Professor
Institut Investigacio Sanitaria Pere Virgili
First Submitted
September 21, 2022
First Posted
September 26, 2022
Study Start
June 25, 2008
Actual (reported)Primary Completion
December 31, 2028
EstimatedAssessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery
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
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 13, 2024
Record last verified: 2024-11
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.
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Source: ClinicalTrials.gov.
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