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Recruiting NCT06226194

Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

— Observational Bariatric Surgery Candidate Obesity, Morbid Genetic Predisposition Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bariatric Surgery Candidate, Obesity, Morbid, Genetic Predisposition, Metabolic Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Obesity is a complex chronic disease, in which both genetic and environmental factors are involved, that shows a great heterogeneity in the response to different weight loss programs. Identifying patients as responder or no responder to the different obesity treatment options is a concept of great interest, both due to the high prevalence of obesity and its high consumption of resources. More than 500,000 surgeries are performed every year around the world, of which approximately 30% will present unsatisfactory results. 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.

Primary outcome measures

  • Genomic markers that can predict the weight change response to bariatric surgery [Time frame: 3 years]
Secondary outcome measures (1)
  • Genomic markers that can predict comorbidities response to bariatric surgery [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Men and women between the ages of 18 and 65 at the time of surgery
  • 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

  • Any previous gastrointestinal surgery
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • IRBLleida — Lleida

Publications

  • 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 (E PMID 34872641
  • 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 PMID 32933882
  • 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. 202 PMID 33398625
  • 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. PMID 32081378
  • 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 Manageme PMID 32640531
  • Vilallonga R, Pereira-Cunill JL, Morales-Conde S, Alarcon I, Breton I, Dominguez-Adame E, Ferrer JV, Ruiz-de-Gordejuela AG, Goday A, Lecube A, Garcia-Almenta EM, Rubio MA, Tinahones FJ, Garcia-Luna PP. A Spanish Society joint SECO and SEEDO approach to the Post-operative management of the patients undergoing surgery for obesity. Obes Surg. 2019 Dec;29(12):3842-3853. doi: 10.1007/s11695-019-04043-8 PMID 31342249
  • Lecube A, Monereo S, Rubio MA, Martinez-de-Icaya P, Marti A, Salvador J, Masmiquel L, Goday A, Bellido D, Lurbe E, Garcia-Almeida JM, Tinahones FJ, Garcia-Luna PP, Palacio E, Gargallo M, Breton I, Morales-Conde S, Caixas A, Menendez E, Puig-Domingo M, Casanueva FF. Prevention, diagnosis, and treatment of obesity. 2016 position statement of the Spanish Society for the Study of Obesity. Endocrinol D PMID 27543006
  • 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. PMID 35514242

Identifiers

NCT: NCT06226194 · IRBLleida

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗