Bariatric Surgery CandidateGENBASUNCT06226194
Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Genetic Predisposition
- How many people
- 6,966 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2024to 29 Nov 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IRBLleida
Lleida, Leida, 25198
Albert Lecube Torelló, PhD, 973702201, alecube@gmail.com
About this study
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
- Medical subject headings
- Obesity, Morbid, Genetic Predisposition to Disease, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic markers that can predict the weight change response to bariatric surgery
Percentage of initial weight change
Measured: 3 years
Secondary outcomes (1)
Genomic markers that can predict comorbidities response to bariatric surgery
Type 2 diabetes mellitus, sleep apnea, fatty liver
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion29 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- 6,966 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- ISCIII
- Responsible party
- Principal investigator, Albert Lecube Torello, Institut de Recerca Biomèdica de Lleida
- Investigators
- Albert Lecube Torelló, PhD, Study chair, Institut de Recerca Biomèdica de LleidaRafael Simo, PhD, Study director, Hospital Universitari Vall d'Hebron Research InstituteMiguel Angel Rubio, PhD, Principal investigator, Instituto de Investigación Sanitaria Hospital Clínico San CarlosFrancisco Tinahones, PhD, Principal investigator, Instituto de Investigación Biomédica de MálagaJavier Escalada, PhD, Principal investigator, Clínica Universidad de Navarra Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226194
- Sponsor's protocol ID
- IRBLleida
- Acronym
- GENBASU
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 (Engl Ed). 2021 Oct;68(8):573-576. doi: 10.1016/j.endien.2021.02.004. Epub 2021 Nov 18. No abstract available.
PubMed 34872641Ballesteros 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.
PubMed 32933882Beisani 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.
PubMed 33398625Caixas 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.
PubMed 32081378Martinez-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.
PubMed 32640531Vilallonga 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.
PubMed 31342249Lecube 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 Diabetes Nutr. 2017 Mar;64 Suppl 1:15-22. doi: 10.1016/j.endonu.2016.07.002. Epub 2016 Aug 16. No abstract available. English, Spanish.
PubMed 27543006Yarnoz-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.
PubMed 35514242Linares-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.
PubMed 35342930Martinez 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.
PubMed 34846686Lecube 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.
PubMed 34253348Torrego-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.
PubMed 34146246Gutierrez-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.
PubMed 34638758Ciudin 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.
PubMed 34683180Nicolau 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.
PubMed 33601956
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility to Predict Weight Loss After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06226194
- Acronym / sponsor ID
- GENBASU / IRBLleida
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid, Genetic Predisposition, Metabolic Syndrome, Weight Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,966 participants (estimated)
- Lead sponsor
- Institut de Recerca Biomèdica de LleidaUniversity, hospital or other
- Collaborators
- ISCIII
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 29 Nov 2028 (estimated)
- First posted
- 26 Jan 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genomic markers that can predict the weight change response to bariatric surgery
Time frame: 3 years
Percentage of initial weight change
1 secondary outcome
Genomic markers that can predict comorbidities response to bariatric surgery
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 34872641Breton 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.
- Background: PubMed 32933882Ballesteros 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.
- Background: PubMed 33398625Beisani 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.
- Background: PubMed 32081378Caixas 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.
- Background: PubMed 32640531Martinez-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.
- Background: PubMed 31342249Vilallonga 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.
- Background: PubMed 27543006Lecube 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 Diabetes Nutr. 2017 Mar;64 Suppl 1:15-22. doi: 10.1016/j.endonu.2016.07.002. Epub 2016 Aug 16. No abstract available. English, Spanish.
- Background: PubMed 35514242Yarnoz-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.
- Background: PubMed 35342930Linares-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.
- Background: PubMed 34846686Martinez 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.
- Background: PubMed 34253348Lecube 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.
- Background: PubMed 34146246Torrego-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.
- 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.
Albert Lecube Torelló, PhD study chair
Institut de Recerca Biomèdica de Lleida
Rafael Simo, PhD study director
Hospital Universitari Vall d'Hebron Research Institute
Miguel Angel Rubio, PhD principal investigator
Instituto de Investigación Sanitaria Hospital Clínico San Carlos
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 Institut de Recerca Biomèdica de Lleida 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Lecube Torelló, PhD (0034973705183, alecube@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic markers that can predict the weight change response to bariatric surgery (time frame: 3 years). 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 NCT06226194, which also lists 26 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 6 Mar 2024.