Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery

NCT06226194 | Recruiting

• 1 other identifier: IRBLleida
• Study Type: observational
• Target: 6,966
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid; Genetic Predisposition; Metabolic Syndrome; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Genomic markers that can predict the weight change response to bariatric surgery

  Percentage of initial weight change

  3 years

Secondary Outcomes (1)

• Genomic markers that can predict comorbidities response to bariatric surgery

  3 years

Study Arms (11)

Lleida

Saliva sample collection and questionnaire

Barcelona

Saliva sample collection and questionnaire

Madrid

Saliva sample collection and questionnaire

Málaga

Saliva sample collection and questionnaire

Santiago de Compostela

Saliva sample collection and questionnaire

Pamplona

Saliva sample collection and questionnaire

León

Saliva sample collection and questionnaire

A Coruña

Saliva sample collection and questionnaire

Mallorca

Saliva sample collection and questionnaire

Tenerife

Saliva sample collection and questionnaire

Las Palmas

Saliva sample collection and questionnaire

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This multicenter retrospective study will be aimed at 6,966 obese patients undergoing BS, whose surgical technique (sleeve gastrectomy vs gastric bypass) has been performed at least 3 years before, evaluating the best combination of genetic and exposomal characteristics (clinical and analytical) that will predict which patients will be responders and non-responders in terms of weight loss.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead
• ISCIII: collaborator

Study Sites (1)

IRBLleida

Lleida, Leida, 25198, Spain

RECRUITING

Related Publications (26)

• 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.

  PMID: 34872641 BACKGROUND

• 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.

  PMID: 32933882 BACKGROUND

• 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.

  PMID: 33398625 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32640531 BACKGROUND

• 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.

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  PMID: 27543006 BACKGROUND

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  PMID: 35514242 BACKGROUND

• 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.

  PMID: 35342930 BACKGROUND

• 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.

  PMID: 34846686 BACKGROUND

• 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.

  PMID: 34253348 BACKGROUND

• 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.

  PMID: 34146246 BACKGROUND

• 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.

  PMID: 34638758 BACKGROUND

• 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.

  PMID: 34683180 BACKGROUND

• 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.

  PMID: 33601956 BACKGROUND

• 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.

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• 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.

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• 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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• Hollanda A, Lecube A, Rubio MA, Sanchez E, Vilarrasa N, Oliva JG, Fernandez-Soto ML, Salas-Salvado J, Ballesteros-Pomar MD, Ciudin A, Torres F, Vidal C, Morales MJ, Valdes S, Pellitero S, Minambres I, Masmiquel L, Goday A, Suarez L, Flores L, Bueno M, Caixas A, Breton I, Camara R, Olbeyra R, Penso R, Jose de la Cruz M, Simo-Servat A, Pereyra-Garcia FM, Lopez-Mezquita ET, Gils A, Fidilio E, Bandres O, Martinez A, Abuin J, Marques-Pamies M, Tuneu L, Arteaga M, Castaner O, Goni F, Arrizabalaga C, Botana MA, Calanas A, Rebollo A. New Metrics to Assess Type 2 Diabetes After Bariatric Surgery: The "Time-Within-Remission Range". J Clin Med. 2020 Apr 9;9(4):1070. doi: 10.3390/jcm9041070.

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Biospecimen

Retention: SAMPLES WITH DNA

Saliva and peripheral blood

MeSH Terms

Conditions

Obesity, Morbid; Genetic Predisposition to Disease; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Study Officials

• Albert Lecube Torelló, PhD

  Institut de Recerca Biomèdica de Lleida

  STUDY CHAIR

• Rafael Simo, PhD

  Vall d'Hebron Research Institute

  STUDY DIRECTOR

• Miguel Angel Rubio, PhD

  Instituto de Investigación Sanitaria Hospital Clínico San Carlos

  PRINCIPAL INVESTIGATOR

• Francisco Tinahones, PhD

  Instituto de Investigación Biomédica de Málaga

  PRINCIPAL INVESTIGATOR

• Javier Escalada, PhD

  Clínica Universidad de Navarra Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Lecube Torelló, PhD

CONTACT

0034973705183; alecube@gmail.com

Eva López

CONTACT

0034973706636; elopez@irblleida.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology Department Arnau de Vilanova University Hospital

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): November 29, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

ES (1)