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dc.contributor.authorHjelmesæth, Jøran
dc.contributor.authorÅsberg, Anders
dc.contributor.authorAndersson, Shalini
dc.contributor.authorSandbu, Rune
dc.contributor.authorRobertsen, Ida
dc.contributor.authorJohnson, Line Kristin
dc.contributor.authorAngeles, Philip Carlo Soriano
dc.contributor.authorHertel, Jens Kristoffer
dc.contributor.authorSkovlund, Eva
dc.contributor.authorHeijer, Maria
dc.contributor.authorEk, Anna-Lena
dc.contributor.authorKrogstad, Veronica
dc.contributor.authorKarlsen, Tor-Ivar
dc.contributor.authorChristensen, Hege Staaland
dc.contributor.authorAndersson, Tommy B
dc.contributor.authorKarlsson, Cecilia
dc.identifier.citationBMJ Open. 2018, 8 (5), 1-10nb_NO
dc.description.abstractIntroduction: Roux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6 weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups. Methods and analysis: This open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6 weeks) and long-term (2 years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24 hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUCoral/AUCiv) of midazolam (CYP3A4 probe), systemic exposure (AUCoral) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers. Ethics and dissemination: The COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants.nb_NO
dc.publisherBMJ Publishing Groupnb_NO
dc.rightsNavngivelse-Ikkekommersiell 4.0 Internasjonal*
dc.titleImpact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)nb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.source.journalBMJ Opennb_NO
dc.description.localcode© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0)nb_NO
cristin.unitnameInstitutt for samfunnsmedisin og sykepleie

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Navngivelse-Ikkekommersiell 4.0 Internasjonal
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