Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol

Introduction: Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgi...

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Autores: Benaiges Foix, David, Goday Arnó, Albert, Flores Le Roux, Juana Antonia, Fitó Colomer, Montserrat, Pozo Mendoza, Óscar J., 1975-, Rodríguez-Morató, Jose, 1987-, Serra, Carme, Pera Román, Manuel, Llauradó Cabot, Gemma, Climent, Elisenda, Castañer, Olga, Ramón Moros, José Manuel, Pedro-Botet, Juan
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/47691
Acceso en línea:http://hdl.handle.net/10230/47691
http://dx.doi.org/10.1136/bmjopen-2020-037712
Access Level:acceso abierto
Palabra clave:Diabetes &amp
endocrinology
Nutrition &amp
dietetics
Surgery
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spelling Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterolBenaiges Foix, DavidGoday Arnó, AlbertFlores Le Roux, Juana AntoniaFitó Colomer, MontserratPozo Mendoza, Óscar J., 1975-Rodríguez-Morató, Jose, 1987-Serra, CarmePera Román, ManuelLlauradó Cabot, GemmaCliment, ElisendaCastañer, OlgaRamón Moros, José ManuelPedro-Botet, JuanDiabetes &ampendocrinologyNutrition &ampdieteticsSurgeryIntroduction: Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgical procedure election. Furthermore, it is also necessary to establish the mechanisms by which LDL cholesterol improves after surgery and whether qualitative and quantitative changes occur in the different lipoprotein subclasses. The first objective is to ascertain whether high LDL cholesterol levels before surgery can be considered an additional factor when selecting the most appropriate surgical procedure for each patient (gastric bypass or sleeve gastrectomy). Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared. Secondary objectives were (1) to compare changes in other lipoproteins and LDL composition and (2) to study the pathophysiologic mechanisms related to LDL cholesterol remission. Methods and analysis: A randomised clinical trial, with intention-to-treat analysis, will be conducted to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy, with a 12-month follow-up. Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40 kg/m2 or ≥35 kg/m2 with significant obesity-related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation. Ethics and dissemination: Ethics approval has been granted by the Parc de Salut Mar Ethics Committee (2019/8471/I). The study and its conclusions regarding the primary and secondary objectives will be presented as manuscripts submitted for peer-reviewed journal publication. Trial registration number: NCT03975478.BMJ Publishing Group202120212020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/47691http://dx.doi.org/10.1136/bmjopen-2020-037712reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésCopyright © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.http://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/476912026-05-29T05:05:01Z
dc.title.none.fl_str_mv Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
title Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
spellingShingle Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
Benaiges Foix, David
Diabetes &amp
endocrinology
Nutrition &amp
dietetics
Surgery
title_short Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
title_full Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
title_fullStr Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
title_full_unstemmed Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
title_sort Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol
dc.creator.none.fl_str_mv Benaiges Foix, David
Goday Arnó, Albert
Flores Le Roux, Juana Antonia
Fitó Colomer, Montserrat
Pozo Mendoza, Óscar J., 1975-
Rodríguez-Morató, Jose, 1987-
Serra, Carme
Pera Román, Manuel
Llauradó Cabot, Gemma
Climent, Elisenda
Castañer, Olga
Ramón Moros, José Manuel
Pedro-Botet, Juan
author Benaiges Foix, David
author_facet Benaiges Foix, David
Goday Arnó, Albert
Flores Le Roux, Juana Antonia
Fitó Colomer, Montserrat
Pozo Mendoza, Óscar J., 1975-
Rodríguez-Morató, Jose, 1987-
Serra, Carme
Pera Román, Manuel
Llauradó Cabot, Gemma
Climent, Elisenda
Castañer, Olga
Ramón Moros, José Manuel
Pedro-Botet, Juan
author_role author
author2 Goday Arnó, Albert
Flores Le Roux, Juana Antonia
Fitó Colomer, Montserrat
Pozo Mendoza, Óscar J., 1975-
Rodríguez-Morató, Jose, 1987-
Serra, Carme
Pera Román, Manuel
Llauradó Cabot, Gemma
Climent, Elisenda
Castañer, Olga
Ramón Moros, José Manuel
Pedro-Botet, Juan
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Diabetes &amp
endocrinology
Nutrition &amp
dietetics
Surgery
topic Diabetes &amp
endocrinology
Nutrition &amp
dietetics
Surgery
description Introduction: Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgical procedure election. Furthermore, it is also necessary to establish the mechanisms by which LDL cholesterol improves after surgery and whether qualitative and quantitative changes occur in the different lipoprotein subclasses. The first objective is to ascertain whether high LDL cholesterol levels before surgery can be considered an additional factor when selecting the most appropriate surgical procedure for each patient (gastric bypass or sleeve gastrectomy). Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared. Secondary objectives were (1) to compare changes in other lipoproteins and LDL composition and (2) to study the pathophysiologic mechanisms related to LDL cholesterol remission. Methods and analysis: A randomised clinical trial, with intention-to-treat analysis, will be conducted to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy, with a 12-month follow-up. Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40 kg/m2 or ≥35 kg/m2 with significant obesity-related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation. Ethics and dissemination: Ethics approval has been granted by the Parc de Salut Mar Ethics Committee (2019/8471/I). The study and its conclusions regarding the primary and secondary objectives will be presented as manuscripts submitted for peer-reviewed journal publication. Trial registration number: NCT03975478.
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/47691
http://dx.doi.org/10.1136/bmjopen-2020-037712
url http://hdl.handle.net/10230/47691
http://dx.doi.org/10.1136/bmjopen-2020-037712
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
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