Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity

NCT06297928 | Completed

• 1 other identifier: 2023/11238/I
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid; Obesity, Metabolically Benign

Keywords

bariatric surgery; Metabolically Unhealthy Obesity; metabolomics; Clinical obesity; subclinical obesity

Outcome Measures

Primary Outcomes (1)

• 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 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

  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)

  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

  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

  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

  Baseline, 3 months, and 12 months after bariatric surgery.

Interventions

baratric surgery PROCEDURE

Participants in this study will undergo bariatric surgery, either gastric bypass or sleeve gastrectomy, based on clinical criteria and consensus from a multidisciplinary team.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (17)

• 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.

  PMID: 25282193 BACKGROUND

• Buchwald 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.

  PMID: 15479938 BACKGROUND

• Dang 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.

  PMID: 34893681 BACKGROUND

• de 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.

  PMID: 25421881 BACKGROUND

• Rawlins 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.

  PMID: 21111688 BACKGROUND

• Fultang 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.

  PMID: 33436532 BACKGROUND

• Kim 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.

  PMID: 36926678 BACKGROUND

• Sun 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.

  PMID: 26915271 BACKGROUND

• Olivier 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.

  PMID: 31561483 BACKGROUND

• Vaz 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.

  PMID: 34855133 BACKGROUND

• Arora 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.

  PMID: 25946120 BACKGROUND

• Kwon 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.

  PMID: 32815103 BACKGROUND

• Stefan 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.

  PMID: 24622321 BACKGROUND

• Caleyachetty 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.

  PMID: 28911506 BACKGROUND

• Soriguer 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.

  PMID: 23559087 BACKGROUND

• Bluher M. Are there still healthy obese patients? Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):341-6. doi: 10.1097/MED.0b013e328357f0a3.

  PMID: 22895358 BACKGROUND

• Goday A, Julia H, de Vargas-Machuca A, Pedro-Botet J, Benavente S, Ramon JM, Pera M, Casajoana A, Villatoro M, Fontane L, Bisbe M, Climent E, Castaner O, Flores Le Roux JA, Benaiges D. Bariatric surgery improves metabolic and nonalcoholic fatty liver disease markers in metabolically healthy patients with morbid obesity at 5 years. Surg Obes Relat Dis. 2021 Dec;17(12):2047-2053. doi: 10.1016/j.soard.2021.07.021. Epub 2021 Aug 12.

  PMID: 34509375 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity, Metabolically Benign

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

ES (1)