Bariatric Surgery CandidateNCT06297928
Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Metabolically Benign
- What is being tested?
- baratric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: The study population will consist of patients who have undergone bariatric surgery at the Hospital del Mar in Barcelona and meet the aforementioned inclusion criteria. These patients will be consecutively selected and must agree to participate in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
In January 2025, a new definition of clinical obesity was proposed by the Lancet Commission, focusing on organ/system dysfunction induced by excess adiposity. In response, this study has expanded its objectives to assess the prevalence, predictors, and metabolomic correlates of clinical obesity and its remission after bariatric surgery.
Read the detailed description
This is a prospective observational study conducted at the bariatric surgery unit. Patients undergo routine assessments and preoperative evaluations by a multidisciplinary team including surgeons, endocrinologists, nutritionists, psychologists, psychiatrists, and anesthesiologists. Clinical evaluations include physical examinations and laboratory tests to detect cardiometabolic comorbidities before surgery. The two bariatric surgery techniques performed in this center are gastric bypass and vertical gastrectomy. The choice of technique is based on clinical criteria and consensus of the multidisciplinary team. After surgery, patients are evaluated at 3, 6, and 12 months through anthropometry, blood pressure measurements, smoking habits assessment, and routine blood analysis. Patients are invited to participate in the OBEMAR registry during the preoperative period. With informed consent, patients authorize the collection of serum and plasma samples at each visit for scientific purposes. Participation in the study does not entail additional visits or procedures beyond standard clinical practice and participation in the OBEMAR registry.
Metabolically Health Status Criteria:
Health status will be defined according to the criteria used by Wildman et al. in the NHANES 1999-2004 study, excluding C-reactive protein measurement. Patients will be classified as metabolically healthy obese (OMS) if they have only one or none of the cardiometabolic factors. Patients with two or more risk factors will be categorized as metabolically unhealthy obese (OME). This classification will be performed before and one year after surgery.
Metabolomics The study will analyze various metabolites related to amino acid metabolism, energy metabolism, and lipid profile. These metabolites will provide insights into metabolic changes before and after bariatric surgery. Specifically, the study will focus on branched-chain amino acids (BCAA), aromatic amino acids (AAA), energy metabolites, and lipid species.
Sample size and origin To ensure statistical power, a sample size calculation was performed based on the anticipated distribution of patients transitioning to metabolically healthy obesity (OMS) or maintaining metabolically unhealthy obesity (OME) status after surgery. It is estimated that 84.4% of patients will transition to OMS, while the remaining 15.6% will remain OME after surgery. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-tailed test, a minimum of 19 subjects in the OME group and 102 in the OMS group are required to detect a difference of 25% or more in the selected metabolites. Assuming a common standard deviation of 35% for these metabolites, a total of 145 patients need to be included to ensure that 121 meet OME criteria before surgery.
Patients for this study will be sourced from the OBEMAR registry, which comprises individuals who have undergone bariatric surgery at the Hospital del Mar. A portion of the patients included in this registry already have sufficient clinical information to classify them as OMS or OME, and their biological samples are stored in a biobank. As of February 2023, complete clinical data and pre- and post-operative samples are available for 70 patients. With approximately 100 surgeries performed annually in our unit, it is anticipated that the desired sample size will be attained by July 2025.
In January 2025, an international expert commission published a new definition of clinical obesity in The Lancet Diabetes \& Endocrinology, shifting the paradigm from traditional risk-based classifications (such as the metabolically healthy/unhealthy obesity concept) to a functional definition based on organ and system-level dysfunctions attributable to excess adiposity. This new definition aims to set a precedent in public health policies, pharmacological treatment indications, and the clinical organization of obesity care. However, it has sparked considerable debate among experts and scientific societies regarding its impact, applicability, and clinical validity.
Given this context, it is essential to generate new knowledge around this concept. Although this study was initially designed to explore a specific metabolic phenotype (metabolically healthy obesity), it now represents a unique opportunity to evaluate the prevalence, predictors, and mechanisms associated with clinical obesity and its remission after bariatric surgery. This adaptation aligns with the research priorities outlined by the expert commission, which emphasize the need to:
Identify biomarkers and/or anthropometric criteria to improve the diagnosis and prognostic stratification of clinical obesity.
Evaluate the efficacy of current anti-obesity interventions in terms of remission or improvement of clinical obesity-not just weight loss or reduced risk of comorbidities.
Understand the degree of weight loss necessary to induce meaningful clinical improvement.
Advance the prevention and treatment of clinical and pre-clinical obesity using a precision medicine approach.
Incorporating these goals, this study will provide valuable insights into how bariatric surgery and metabolomic profiles relate to the new framework of clinical obesity, potentially influencing future therapeutic strategies and clinical trial design.
- Being tested
- baratric surgery
- Keywords
- bariatric surgery, Metabolically Unhealthy Obesity, metabolomics, Clinical obesity, subclinical obesity
- Medical subject headings
- Obesity, Morbid, Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baratric surgeryProcedure or surgery
Participants in this study will undergo bariatric surgery, either gastric bypass or sleeve gastrectomy, based on clinical criteria and consensus from a multidisciplinary team.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The transition from MUO to MHO status will be assessed at one year after bariatric surgery.
Secondary outcomes (5)
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.
Measured: Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery
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.
Measured: Baseline metabolomic profiling will be conducted before surgery. The evolution of metabolomic profiles will be assessed at 3 and 12 months post-surgery.
Prevalence of Clinical Obesity at Baseline and Rate of Transition to Subclinical Obesity One Year After Bariatric Surgery
This objective seeks to quantify the prevalence of clinical obesity in patients undergoing bariatric surgery according to the criteria established by the 2025 Lancet Commission. It will also assess the rate of transition from clinical to subclinical obesity status at 12 months postoperatively.
Measured: Assessed at baseline and at 12 months after bariatric surgery.
Identification of Metabolic Signatures Using LC-MS/MS Predicting Transition from Clinical Obesity to Subclinical Obesity Status
This secondary objective aims to identify metabolomic signatures present in patients with clinical obesity (as defined by the 2025 Lancet Commission) before bariatric surgery, which can predict the transition to subclinical obesity status one year after the intervention. Among patients classified as having clinical obesity preoperatively, comparisons will be made between those who remain in clinical obesity status and those who transition to subclinical obesity at 12 months. Baseline metabolomic profiles will be measured using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and compared between these groups.
Measured: Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery.
Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Between Patients With Persistent Clinical Obesity and Those Transitioning to Subclinical Obesity
This objective aims to compare the metabolomic changes over time in patients classified as having clinical obesity before bariatric surgery, based on the 2025 Lancet Commission definition. Patients who maintain clinical obesity at 12 months postoperatively will be compared with those who transition to subclinical obesity. Longitudinal changes in metabolomic profiles, measured by LC-MS/MS at baseline, 3 months, and 12 months, will be analyzed to identify metabolic pathways associated with organ/system recovery and clinical improvement after bariatric surgery.
Measured: Baseline, 3 months, and 12 months after bariatric surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297928
- Sponsor's protocol ID
- 2023/11238/I
- Other IDs
- 2023
- Status last verified
- May 2025
- First submitted
- 22 Feb 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goday A, Benaiges D, Parri A, Ramon JM, Flores-Le Roux JA, Pedro Botet J; Obemar Group. Can bariatric surgery improve cardiovascular risk factors in the metabolically healthy but morbidly obese patient? Surg Obes Relat Dis. 2014 Sep-Oct;10(5):871-6. doi: 10.1016/j.soard.2014.04.022. Epub 2014 May 2.
PubMed 25282193Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Dang JT, Mocanu V, Park H, Laffin M, Tran C, Hotte N, Karmali S, Birch DW, Madsen K. Ileal microbial shifts after Roux-en-Y gastric bypass orchestrate changes in glucose metabolism through modulation of bile acids and L-cell adaptation. Sci Rep. 2021 Dec 10;11(1):23813. doi: 10.1038/s41598-021-03396-4.
PubMed 34893681de Hollanda A, Ruiz T, Jimenez A, Flores L, Lacy A, Vidal J. Patterns of Weight Loss Response Following Gastric Bypass and Sleeve Gastrectomy. Obes Surg. 2015 Jul;25(7):1177-83. doi: 10.1007/s11695-014-1512-7.
PubMed 25421881Rawlins ML, Teel D 2nd, Hedgcorth K, Maguire JP. Revision of Roux-en-Y gastric bypass to distal bypass for failed weight loss. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):45-9. doi: 10.1016/j.soard.2010.08.013. Epub 2010 Sep 15.
PubMed 21111688Fultang J, Chinaka U, Rankin J, Bakhshi A, Ali A. Preoperative Bariatric Surgery Predictors of Type 2 Diabetes Remission. J Obes Metab Syndr. 2021 Jun 30;30(2):104-114. doi: 10.7570/jomes20084.
PubMed 33436532Kim EY. Definition, Mechanisms and Predictors of Weight Loss Failure After Bariatric Surgery. J Metab Bariatr Surg. 2022 Dec;11(2):39-48. doi: 10.17476/jmbs.2022.11.2.39. Epub 2023 Feb 3.
PubMed 36926678Sun YV, Hu YJ. Integrative Analysis of Multi-omics Data for Discovery and Functional Studies of Complex Human Diseases. Adv Genet. 2016;93:147-90. doi: 10.1016/bs.adgen.2015.11.004. Epub 2016 Jan 25.
PubMed 26915271Olivier M, Asmis R, Hawkins GA, Howard TD, Cox LA. The Need for Multi-Omics Biomarker Signatures in Precision Medicine. Int J Mol Sci. 2019 Sep 26;20(19):4781. doi: 10.3390/ijms20194781.
PubMed 31561483Vaz M, Pereira SS, Monteiro MP. Metabolomic signatures after bariatric surgery - a systematic review. Rev Endocr Metab Disord. 2022 Jun;23(3):503-519. doi: 10.1007/s11154-021-09695-5. Epub 2021 Dec 2.
PubMed 34855133Arora T, Velagapudi V, Pournaras DJ, Welbourn R, le Roux CW, Oresic M, Backhed F. Roux-en-Y Gastric Bypass Surgery Induces Early Plasma Metabolomic and Lipidomic Alterations in Humans Associated with Diabetes Remission. PLoS One. 2015 May 6;10(5):e0126401. doi: 10.1371/journal.pone.0126401. eCollection 2015.
PubMed 25946120Kwon Y, Jang M, Lee Y, Ha J, Park S. Metabolomic Analysis of the Improvements in Insulin Secretion and Resistance After Sleeve Gastrectomy: Implications of the Novel Biomarkers. Obes Surg. 2021 Jan;31(1):43-52. doi: 10.1007/s11695-020-04925-2. Epub 2020 Aug 19.
PubMed 32815103Stefan N, Haring HU, Hu FB, Schulze MB. Metabolically healthy obesity: epidemiology, mechanisms, and clinical implications. Lancet Diabetes Endocrinol. 2013 Oct;1(2):152-62. doi: 10.1016/S2213-8587(13)70062-7. Epub 2013 Aug 30.
PubMed 24622321Caleyachetty R, Thomas GN, Toulis KA, Mohammed N, Gokhale KM, Balachandran K, Nirantharakumar K. Metabolically Healthy Obese and Incident Cardiovascular Disease Events Among 3.5 Million Men and Women. J Am Coll Cardiol. 2017 Sep 19;70(12):1429-1437. doi: 10.1016/j.jacc.2017.07.763.
PubMed 28911506Soriguer F, Gutierrez-Repiso C, Rubio-Martin E, Garcia-Fuentes E, Almaraz MC, Colomo N, Esteva de Antonio I, de Adana MS, Chaves FJ, Morcillo S, Valdes S, Rojo-Martinez G. Metabolically healthy but obese, a matter of time? Findings from the prospective Pizarra study. J Clin Endocrinol Metab. 2013 Jun;98(6):2318-25. doi: 10.1210/jc.2012-4253. Epub 2013 Apr 4.
PubMed 23559087
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity: Advancing Precision Medicine for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT06297928
- Acronym / sponsor ID
- 2023/11238/I
- Keywords
- bariatric surgery, Metabolically Unhealthy Obesity, metabolomics, Clinical obesity, subclinical obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In January 2025, a new definition of clinical obesity was proposed by the Lancet Commission, focusing on organ/system dysfunction induced by excess adiposity. In response, this study has expanded its objectives to assess the prevalence, predictors, and metabolomic correlates of clinical obesity and its remission after bariatric surgery.
Detailed description
This is a prospective observational study conducted at the bariatric surgery unit. Patients undergo routine assessments and preoperative evaluations by a multidisciplinary team including surgeons, endocrinologists, nutritionists, psychologists, psychiatrists, and anesthesiologists. Clinical evaluations include physical examinations and laboratory tests to detect cardiometabolic comorbidities before surgery. The two bariatric surgery techniques performed in this center are gastric bypass and vertical gastrectomy. The choice of technique is based on clinical criteria and consensus of the multidisciplinary team. After surgery, patients are evaluated at 3, 6, and 12 months through anthropometry, blood pressure measurements, smoking habits assessment, and routine blood analysis. Patients are invited to participate in the OBEMAR registry during the preoperative period. With informed consent, patients authorize the collection of serum and plasma samples at each visit for scientific purposes. Participation in the study does not entail additional visits or procedures beyond standard clinical practice and participation in the OBEMAR registry.
Metabolically Health Status Criteria:
Health status will be defined according to the criteria used by Wildman et al. in the NHANES 1999-2004 study, excluding C-reactive protein measurement. Patients will be classified as metabolically healthy obese (OMS) if they have only one or none of the cardiometabolic factors. Patients with two or more risk factors will be categorized as metabolically unhealthy obese (OME). This classification will be performed before and one year after surgery.
Metabolomics The study will analyze various metabolites related to amino acid metabolism, energy metabolism, and lipid profile. These metabolites will provide insights into metabolic changes before and after bariatric surgery. Specifically, the study will focus on branched-chain amino acids (BCAA), aromatic amino acids (AAA), energy metabolites, and lipid species.
Sample size and origin To ensure statistical power, a sample size calculation was performed based on the anticipated distribution of patients transitioning to metabolically healthy obesity (OMS) or maintaining metabolically unhealthy obesity (OME) status after surgery. It is estimated that 84.4% of patients will transition to OMS, while the remaining 15.6% will remain OME after surgery. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-tailed test, a minimum of 19 subjects in the OME group and 102 in the OMS group are required to detect a difference of 25% or more in the selected metabolites. Assuming a common standard deviation of 35% for these metabolites, a total of 145 patients need to be included to ensure that 121 meet OME criteria before surgery.
Patients for this study will be sourced from the OBEMAR registry, which comprises individuals who have undergone bariatric surgery at the Hospital del Mar. A portion of the patients included in this registry already have sufficient clinical information to classify them as OMS or OME, and their biological samples are stored in a biobank. As of February 2023, complete clinical data and pre- and post-operative samples are available for 70 patients. With approximately 100 surgeries performed annually in our unit, it is anticipated that the desired sample size will be attained by July 2025.
In January 2025, an international expert commission published a new definition of clinical obesity in The Lancet Diabetes \& Endocrinology, shifting the paradigm from traditional risk-based classifications (such as the metabolically healthy/unhealthy obesity concept) to a functional definition based on organ and system-level dysfunctions attributable to excess adiposity. This new definition aims to set a precedent in public health policies, pharmacological treatment indications, and the clinical organization of obesity care. However, it has sparked considerable debate among experts and scientific societies regarding its impact, applicability, and clinical validity.
Given this context, it is essential to generate new knowledge around this concept. Although this study was initially designed to explore a specific metabolic phenotype (metabolically healthy obesity), it now represents a unique opportunity to evaluate the prevalence, predictors, and mechanisms associated with clinical obesity and its remission after bariatric surgery. This adaptation aligns with the research priorities outlined by the expert commission, which emphasize the need to:
Identify biomarkers and/or anthropometric criteria to improve the diagnosis and prognostic stratification of clinical obesity.
Evaluate the efficacy of current anti-obesity interventions in terms of remission or improvement of clinical obesity-not just weight loss or reduced risk of comorbidities.
Understand the degree of weight loss necessary to induce meaningful clinical improvement.
Advance the prevention and treatment of clinical and pre-clinical obesity using a precision medicine approach.
Incorporating these goals, this study will provide valuable insights into how bariatric surgery and metabolomic profiles relate to the new framework of clinical obesity, potentially influencing future therapeutic strategies and clinical trial design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study population will consist of patients who have undergone bariatric surgery at the Hospital del Mar in Barcelona and meet the aforementioned inclusion criteria. These patients will be consecutively selected and must agree to participate in the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| baratric surgeryParticipants in this study will undergo bariatric surgery, either gastric bypass or sleeve gastrectomy, based on clinical criteria and consensus from a multidisciplinary team. | Procedure or surgery | – |
Primary outcome
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
Time frame: The transition from MUO to MHO status will be assessed at one year after bariatric surgery.
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
5 secondary outcomes
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
Time frame: Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery
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)
Time frame: Baseline metabolomic profiling will be conducted before surgery. The evolution of metabolomic profiles will be assessed at 3 and 12 months post-surgery.
Prevalence of Clinical Obesity at Baseline and Rate of Transition to Subclinical Obesity One Year After Bariatric Surgery
Time frame: Assessed at baseline and at 12 months after bariatric surgery.
Identification of Metabolic Signatures Using LC-MS/MS Predicting Transition from Clinical Obesity to Subclinical Obesity Status
Time frame: Metabolomic changes will be assessed at 3 and 12 months after bariatric surgery.
Comparison of Metabolomic Changes Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Between Patients With Persistent Clinical Obesity and Those Transitioning to Subclinical Obesity
Time frame: Baseline, 3 months, and 12 months after bariatric surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 25282193Goday A, Benaiges D, Parri A, Ramon JM, Flores-Le Roux JA, Pedro Botet J; Obemar Group. Can bariatric surgery improve cardiovascular risk factors in the metabolically healthy but morbidly obese patient? Surg Obes Relat Dis. 2014 Sep-Oct;10(5):871-6. doi: 10.1016/j.soard.2014.04.022. Epub 2014 May 2.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Background: PubMed 34893681Dang JT, Mocanu V, Park H, Laffin M, Tran C, Hotte N, Karmali S, Birch DW, Madsen K. Ileal microbial shifts after Roux-en-Y gastric bypass orchestrate changes in glucose metabolism through modulation of bile acids and L-cell adaptation. Sci Rep. 2021 Dec 10;11(1):23813. doi: 10.1038/s41598-021-03396-4.
- Background: PubMed 25421881de Hollanda A, Ruiz T, Jimenez A, Flores L, Lacy A, Vidal J. Patterns of Weight Loss Response Following Gastric Bypass and Sleeve Gastrectomy. Obes Surg. 2015 Jul;25(7):1177-83. doi: 10.1007/s11695-014-1512-7.
- Background: PubMed 21111688Rawlins ML, Teel D 2nd, Hedgcorth K, Maguire JP. Revision of Roux-en-Y gastric bypass to distal bypass for failed weight loss. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):45-9. doi: 10.1016/j.soard.2010.08.013. Epub 2010 Sep 15.
- Background: PubMed 33436532Fultang J, Chinaka U, Rankin J, Bakhshi A, Ali A. Preoperative Bariatric Surgery Predictors of Type 2 Diabetes Remission. J Obes Metab Syndr. 2021 Jun 30;30(2):104-114. doi: 10.7570/jomes20084.
- Background: PubMed 36926678Kim EY. Definition, Mechanisms and Predictors of Weight Loss Failure After Bariatric Surgery. J Metab Bariatr Surg. 2022 Dec;11(2):39-48. doi: 10.17476/jmbs.2022.11.2.39. Epub 2023 Feb 3.
- Background: PubMed 26915271Sun YV, Hu YJ. Integrative Analysis of Multi-omics Data for Discovery and Functional Studies of Complex Human Diseases. Adv Genet. 2016;93:147-90. doi: 10.1016/bs.adgen.2015.11.004. Epub 2016 Jan 25.
- Background: PubMed 31561483Olivier M, Asmis R, Hawkins GA, Howard TD, Cox LA. The Need for Multi-Omics Biomarker Signatures in Precision Medicine. Int J Mol Sci. 2019 Sep 26;20(19):4781. doi: 10.3390/ijms20194781.
- Background: PubMed 34855133Vaz M, Pereira SS, Monteiro MP. Metabolomic signatures after bariatric surgery - a systematic review. Rev Endocr Metab Disord. 2022 Jun;23(3):503-519. doi: 10.1007/s11154-021-09695-5. Epub 2021 Dec 2.
- Background: PubMed 25946120Arora T, Velagapudi V, Pournaras DJ, Welbourn R, le Roux CW, Oresic M, Backhed F. Roux-en-Y Gastric Bypass Surgery Induces Early Plasma Metabolomic and Lipidomic Alterations in Humans Associated with Diabetes Remission. PLoS One. 2015 May 6;10(5):e0126401. doi: 10.1371/journal.pone.0126401. eCollection 2015.
- Background: PubMed 32815103Kwon Y, Jang M, Lee Y, Ha J, Park S. Metabolomic Analysis of the Improvements in Insulin Secretion and Resistance After Sleeve Gastrectomy: Implications of the Novel Biomarkers. Obes Surg. 2021 Jan;31(1):43-52. doi: 10.1007/s11695-020-04925-2. Epub 2020 Aug 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: The transition from MUO to MHO status will be assessed at one year after bariatric surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297928, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.