Bariatric Surgery Candidate Clinical Trial
Official title:
Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity: Advancing Precision Medicine for the Treatment of Obesity
The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are: - Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery? - How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery? - What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery? Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery.
Status | Recruiting |
Enrollment | 145 |
Est. completion date | December 31, 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: Patients undergoing bariatric surgery at the Hospital del Mar in Barcelona. Criteria for bariatric surgery are: - Ages between 18 and 60 years. - Body Mass Index (BMI) equal to or greater than 40, or equal to or greater than 35 kg/m2 with at least one obesity-related comorbidity (type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnea syndrome). - Previous failure with conventional treatment involving diet and exercise. Exclusion Criteria: - History of previous bariatric surgery. - Presence of severe psychiatric disorders, severe eating disorders, alcohol or drug abuse. - Contraindications for major abdominal surgery, active gastric ulcer, severe liver disease. Pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of Metabolic Signatures Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Analysis Predicting Transition from Metabolically Unhealthy Obesity (MUO) to Metabolically Healthy Obesity (MHO) Status | The primary objective of this study is to identify metabolic signatures present in patients with metabolically unhealthy obesity (MUO) before bariatric surgery, which can predict the transition to metabolically healthy obesity (MHO) status one year after the intervention.
For patients meeting the criteria for MUO before surgery, a comparison will be made between those who remain MUO at 12 months post-intervention and those who transition to MHO. The baseline metabolomic profile, measured using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), will be compared between these groups |
The transition from MUO to MHO status will be assessed at one year after bariatric surgery. | |
Secondary | Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) between Patients with Persistent Metabolically Unhealthy Obesity (MUO) and Those Transitioning to Metabolically Healthy Obesity (MHO) Status | The secondary objective of this study is to compare the changes in metabolomic profiles between patients with persistent metabolically unhealthy obesity (MUO) and those who transition to metabolically healthy obesity (MHO) status one year after bariatric surgery. We aim to elucidate the metabolic pathways associated with successful metabolic health improvement following surgery. | Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery | |
Secondary | Comparison of Baseline Metabolomic Profile and Its Evolution Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) after Surgery between Patients with Metabolically Healthy Obesity (MHO) and Metabolically Unhealthy Obesity (MUO) | This study aims to compare the baseline metabolomic profiles and their evolution after surgery between patients with metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO) using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) analysis. We will compare the metabolic signatures of patients classified as MHO and MUO before bariatric surgery. Specifically, we will compare the baseline metabolomic profiles and the changes in the metabolome at 3 and 12 months post-surgery. This analysis will provide insights into the metabolic mechanisms underlying metabolic health improvement after bariatric surgery. | Baseline metabolomic profiling will be conducted before surgery. The evolution of metabolomic profiles will be assessed at 3 and 12 months post-surgery. |
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