Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
NCT ID: NCT06226194
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6966 participants
OBSERVATIONAL
2024-03-15
2028-11-29
Brief Summary
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The general objective is to carry out a multi-omics approach for the discovery and validation of markers of weight response to bariatric surgery (BS) in a large sample of people with severe obesity (n=6,966 men and women who underwent sleeve gastrectomy or gastric bypass, including an additional external validation set). Thus, the investigators want to know the integrated contribution of several genomic markers (Genome Wide Association study, GWAs), new clinical and analytical variables (human exposome concept) and gender perspective to the prediction of response to the intervention at 12 month and its long-term longitudinal maintenance (3 years). The investigators intend, therefore, to provide new evidence to advance towards precision medicine. The investigators will focus our attention also on identifying those patients who, after being classified at the weight loss nadir as responders experienced weight regain.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lleida
Saliva sample collection and questionnaire
No interventions assigned to this group
Barcelona
Saliva sample collection and questionnaire
No interventions assigned to this group
Madrid
Saliva sample collection and questionnaire
No interventions assigned to this group
Málaga
Saliva sample collection and questionnaire
No interventions assigned to this group
Santiago de Compostela
Saliva sample collection and questionnaire
No interventions assigned to this group
Pamplona
Saliva sample collection and questionnaire
No interventions assigned to this group
León
Saliva sample collection and questionnaire
No interventions assigned to this group
A Coruña
Saliva sample collection and questionnaire
No interventions assigned to this group
Mallorca
Saliva sample collection and questionnaire
No interventions assigned to this group
Tenerife
Saliva sample collection and questionnaire
No interventions assigned to this group
Las Palmas
Saliva sample collection and questionnaire
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* SG or RYBP as bariatric procedure.
* With a BMI≥35.0 kg/m2 with one or more comorbidities or a BMI\>40.0 kg/m2 at the time of surgery.
* Provision of an informed consent form signed and personally dated by the patient.
* With available baseline data (anthropometric, analytical, surgical procedure, pharmacological therapies, and obesity-related comorbidities).
Exclusion Criteria
* Treatment with any approved antiobesity drug in Spain (orlistat, liraglutide 3.0 mg and/or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years following BS
* End stage kidney disease (eGFR \<15 ml/min/1.73m2) or liver cirrhosis at baseline
* Patients who developed any major medical conditions that limits the practice of a healthy life within normal limits (advanced cardiovascular disease or heart failure, stroke with neurological sequelae, chronic pulmonary obstructive disease with dyspnea at minimal exertion, severe joint pathology, end stage renal failure, or active cancer)
* Known type 1 diabetes or LADA diabetes
* Women who become pregnant during the follow-up period
* Current drug or alcohol abuse
* Uncontrolled psychiatric illness or eating disorders developed during the follow-up period.
18 Years
65 Years
ALL
No
Sponsors
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ISCIII
UNKNOWN
Institut de Recerca Biomèdica de Lleida
OTHER
Responsible Party
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Albert Lecube Torello
Head of Endocrinology Department Arnau de Vilanova University Hospital
Principal Investigators
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Albert Lecube Torelló, PhD
Role: STUDY_CHAIR
Institut de Recerca Biomèdica de Lleida
Rafael Simo, PhD
Role: STUDY_DIRECTOR
Vall d'Hebron Research Institute
Miguel Angel Rubio, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Sanitaria Hospital Clínico San Carlos
Francisco Tinahones, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Biomédica de Málaga
Javier Escalada, PhD
Role: PRINCIPAL_INVESTIGATOR
Clínica Universidad de Navarra Institute
Locations
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IRBLleida
Lleida, Leida, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Breton I, de Hollanda A, Vilarrasa N, Rubio Herrera MA, Lecube A, Salvador J, Garcia-Luna PP, Tinahones FJ, Sanchez Santos R, Gomez Huelgas R, Carretero Gomez J, Moize V, Polo Garcia J, Tranche Iparraguirre S, Fernandez-Pro Ledesma A, Escalada J; representing SEEN, SEEDO, SECO, SEMI, SEDYN, SEMERGEN, semFYC and SEMG. Obesity and COVID-19. A necessary position statement. Endocrinol Diabetes Nutr (Engl Ed). 2021 Oct;68(8):573-576. doi: 10.1016/j.endien.2021.02.004. Epub 2021 Nov 18. No abstract available.
Ballesteros Pomar MD, Vilarrasa Garcia N, Rubio Herrera MA, Barahona MJ, Bueno M, Caixas A, Calanas Continente A, Ciudin A, Cordido F, de Hollanda A, Diaz MJ, Flores L, Garcia Luna PP, Garcia Perez-Sevillano F, Goday A, Lecube A, Lopez Gomez JJ, Minambres I, Morales Gorria MJ, Morinigo R, Nicolau J, Pellitero S, Salvador J, Valdes S, Breton Lesmes I. The SEEN comprehensive clinical survey of adult obesity: Executive summary. Endocrinol Diabetes Nutr (Engl Ed). 2021 Feb;68(2):130-136. doi: 10.1016/j.endinu.2020.05.003. Epub 2020 Sep 12. English, Spanish.
Beisani M, Sabench Pereferrer F, Vilallonga R, Gonzalez Lopez O, Molina Lopez A, Del Castillo Dejardin D, Garcia Ruiz de Gordejuela A, Fort Lopez-Barajas JM, Armengol Carrasco M; Members of the Obesity Section of the Spanish Surgical Association Collaborative Group. Seeking an Initial-Weight-Independent Metric in a Mediterranean Cohort of Gastric Bypass Patients: the %AWL Revisited. Obes Surg. 2021 Apr;31(4):1524-1532. doi: 10.1007/s11695-020-05154-3. Epub 2021 Jan 4.
Caixas A, Villaro M, Arraiza C, Montalva JC, Lecube A, Fernandez-Garcia JM, Corio R, Bellido D, Llisterri JL, Tinahones FJ. SEEDO-SEMERGEN consensus document on continuous care of obesity between Primary Care and Specialist Hospital Units 2019. Med Clin (Barc). 2020 Sep 25;155(6):267.e1-267.e11. doi: 10.1016/j.medcli.2019.10.014. Epub 2020 Feb 17. English, Spanish.
Martinez-Ortega AJ, Olveira G, Pereira-Cunill JL, Arraiza-Irigoyen C, Garcia-Almeida JM, Irles Rocamora JA, Molina-Puerta MJ, Molina Soria JB, Rabat-Restrepo JM, Rebollo-Perez MI, Serrano-Aguayo MP, Tenorio-Jimenez C, Vilches-Lopez FJ, Garcia-Luna PP. Recommendations Based on Evidence by the Andalusian Group for Nutrition Reflection and Investigation (GARIN) for the Pre- and Postoperative Management of Patients Undergoing Obesity Surgery. Nutrients. 2020 Jul 6;12(7):2002. doi: 10.3390/nu12072002.
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Yarnoz-Esquiroz P, Olazaran L, Aguas-Ayesa M, Perdomo CM, Garcia-Goni M, Silva C, Fernandez-Formoso JA, Escalada J, Montecucco F, Portincasa P, Fruhbeck G. 'Obesities': Position statement on a complex disease entity with multifaceted drivers. Eur J Clin Invest. 2022 Jul;52(7):e13811. doi: 10.1111/eci.13811. Epub 2022 May 12.
Linares-Pineda TM, Boughanem H, Gutierrez-Repiso C, Macias-Gonzalez M, Andres-Leon E, Rojo-Martinez G, Valdes S, Tinahones FJ, Morcillo S. Epigenetic changes in the metabolically healthy obese: A case-control versus a prospective study. Eur J Clin Invest. 2022 Aug;52(8):e13783. doi: 10.1111/eci.13783. Epub 2022 Apr 11. No abstract available.
Martinez MC, Meli EF, Candia FP, Filippi F, Vilallonga R, Cordero E, Hernandez I, Eguinoa AZ, Burgos R, Vila A, Simo R, Ciudin A. The Impact of Bariatric Surgery on the Muscle Mass in Patients with Obesity: 2-Year Follow-up. Obes Surg. 2022 Mar;32(3):625-633. doi: 10.1007/s11695-021-05815-x. Epub 2021 Nov 30.
Lecube A, Ciudin A. A long and stony road to the correct treatment of obesity. Med Clin (Barc). 2021 Aug 27;157(4):176-177. doi: 10.1016/j.medcli.2021.06.004. Epub 2021 Jul 10. No abstract available. English, Spanish.
Torrego-Ellacuria M, Barabash A, Larrad-Sainz A, Hernandez-Nunez GM, Matia-Martin P, Perez-Ferre N, Marcuello C, Sanchez-Pernaute A, Torres AJ, Calle-Pascual AL, Rubio MA. Weight Regain Outcomes After Bariatric Surgery in the Long-term Follow-up: Role of Preoperative Factors. Obes Surg. 2021 Sep;31(9):3947-3955. doi: 10.1007/s11695-021-05497-5. Epub 2021 Jun 19.
Gutierrez-Repiso C, Linares-Pineda TM, Gonzalez-Jimenez A, Aguilar-Lineros F, Valdes S, Soriguer F, Rojo-Martinez G, Tinahones FJ, Morcillo S. Epigenetic Biomarkers of Transition from Metabolically Healthy Obesity to Metabolically Unhealthy Obesity Phenotype: A Prospective Study. Int J Mol Sci. 2021 Sep 27;22(19):10417. doi: 10.3390/ijms221910417.
Ciudin A, Fidilio E, Gutierrez-Carrasquilla L, Caixas A, Vilarrasa N, Pellitero S, Simo-Servat A, Vilallonga R, Ruiz A, de la Fuente M, Luna A, Sanchez E, Rigla M, Hernandez C, Salas E, Simo R, Lecube A. A Clinical-Genetic Score for Predicting Weight Loss after Bariatric Surgery: The OBEGEN Study. J Pers Med. 2021 Oct 17;11(10):1040. doi: 10.3390/jpm11101040.
Nicolau J, Dotres K, Ayala L, Rodriguez I, Pascual S, Sanchis P, Bonet A, Tamayo MI, Arteaga M, Fortuny R, Cifuentes A, Masmiquel L. Long-Term Prevalence of Food Addiction Among Bariatric Surgery Patients: Influence on Metabolic and Psychological Outcomes. Metab Syndr Relat Disord. 2021 Apr;19(3):152-158. doi: 10.1089/met.2020.0079. Epub 2021 Feb 18.
Fidilio E, Comas M, Giribes M, Cardenas G, Vilallonga R, Palma F, Pelaez RB, Simo R, Ciudin A. Evaluation of Resting Energy Expenditure in Subjects with Severe Obesity and Its Evolution After Bariatric Surgery. Obes Surg. 2021 Oct;31(10):4347-4355. doi: 10.1007/s11695-021-05578-5. Epub 2021 Aug 3.
Cornejo-Pareja I, Molina-Vega M, Gomez-Perez AM, Damas-Fuentes M, Tinahones FJ. Factors Related to Weight Loss Maintenance in the Medium-Long Term after Bariatric Surgery: A Review. J Clin Med. 2021 Apr 16;10(8):1739. doi: 10.3390/jcm10081739.
Alvarez-Bermudez MD, Martin-Reyes F, Ocana-Wilhelmi L, Moreno-Ruiz FJ, Torres JA, Fernandez-Garcia D, Valdes S, Moreno-Morales N, Garcia-Fuentes E, Tinahones FJ, Garrido-Sanchez L. Variables Associated with Short-Term Weight Loss in a Cohort of Patients with Morbid Obesity According to Age and Three Types of Bariatric Surgery. J Clin Med. 2020 Nov 2;9(11):3537. doi: 10.3390/jcm9113537.
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Other Identifiers
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IRBLleida
Identifier Type: -
Identifier Source: org_study_id
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