Evidence map›Paper›PMID 29844102›Full record

ArticleBMJ open2018

Impact 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).

Jøran Hjelmesæth, Anders Åsberg, Shalini Andersson, Rune Sandbu, Ida Robertsen, Line Kristin Johnson, Philip Carlo Angeles, Jens Kristoffer Hertel, Eva Skovlund, Maria Heijer and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02386917 (Impact of Body Weight, Low Calorie Diet and Gastric Bypass on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02386917 naactive not recruitingnot on this map

Impact of Body Weight, Low Calorie Diet and Gastric Bypass on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers

TypeinterventionalSponsorThe Hospital of VestfoldRan2015 to 2028Enrolled100ConditionsObesityArmsGastric bypass, Very low calorie diet
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 5 countries.

Jøran Hjelmesæth *The Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Anders Åsberg *Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
Shalini AnderssonDrug Metabolism and Pharmacokinetics, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca Gothenburg, Gothenburg, Sweden.
Rune SandbuThe Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Ida RobertsenDepartment of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
Line Kristin JohnsonThe Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Philip Carlo AngelesThe Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Jens Kristoffer HertelThe Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Eva SkovlundDepartment of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.
Maria HeijerStudy Operations, Early Clinical Development, IMED Biotech Unit, AstraZeneca Gothenburg, Gothenburg, Sweden.
Anna-Lena EkStudy Operations, Early Clinical Development, IMED Biotech Unit, AstraZeneca Gothenburg, Gothenburg, Sweden.
Veronica KrogstadDepartment of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
Tor-Ivar KarlsenThe Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Hege ChristensenDepartment of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway.
Tommy B AnderssonDrug Metabolism and Pharmacokinetics, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca Gothenburg, Gothenburg, Sweden.
Cecilia KarlssonCardiovascular, Renal and Metabolism Translational Medicine Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca Gothenburg, Gothenburg, Sweden.
University of Oslo · NOSykehuset i Vestfold · NOAstraZeneca (Sweden) · SEKarolinska Institutet · SENorwegian University of Science and Technology · NOUniversity of Agder · NOUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRoux-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 (AUC 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. TRIAL REGISTRATION NUMBER: NCT02386917.

Indexed as

BiomarkersPharmacokineticsBiological AvailabilityBody CompositionCaloric RestrictionCardiovascular DiseasesClinical Trials as TopicFemaleGastric BypassHumansLinear ModelsMaleNorwayObesity, MorbidPharmaceutical PreparationsRisk FactorsBiomarkersPharmaceutical Preparationsbasic sciencescardiologyclinical pharmacology

Identifiers

PMID29844102
PMCPMC5988193
OpenAlexW2806633542

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.