Evidence map›Paper›PMID 31167860›Full record

ArticleBMJ open2019

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function in subjects with morbid obesity: a protocol for the Obesity

Heidi Borgeraas, Jøran Hjelmesæth, Kåre Inge Birkeland, Farhat Fatima, John Olav Grimnes, Hanne L Gulseth, Erling Halvorsen, Jens Kristoffer Hertel, Tor Olav Widerøe Hillestad, Line Kristin Johnson and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01778738 (Glycaemia, Insulin Secretion and Action in Morbidly Obese Subjects With Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01778738 nacompletednot on this map

Glycaemia, Insulin Secretion and Action in Morbidly Obese Subjects With Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study

TypeinterventionalSponsorSykehuset i Vestfold HFRan2013 to 2022Enrolled125ConditionsType 2 Diabetes, Morbid ObesityArmsBariatric surgery, either gastric bypass surgery or sleeve gastrectomy, Sleeve gastrecomy, Bastric bypass
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
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

22 authors.

Heidi BorgeraasThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Jøran HjelmesæthThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Kåre Inge BirkelandDepartment of Transplantation, Oslo University Hospital, Oslo, Norway.
Farhat FatimaThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
John Olav GrimnesDepartment of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.
Hanne L GulsethDepartment of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway.
Erling HalvorsenDepartment of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.
Jens Kristoffer HertelThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Tor Olav Widerøe HillestadDepartment of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.
Line Kristin JohnsonThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Tor-Ivar KarlsenThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Ronette L KolotkinQuality of Life Consulting, PLLC, Durham, North Carolina, USA.
Nils Petter KvanDepartment of Radiology, Vestfold Hospital Trust, Tønsberg, Norway.
Morten LindbergDepartment of Biochemistry, Vestfold Hospital Trust, Tønsberg, Norway.
Jolanta LorentzenThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Njord NordstrandThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Rune SandbuThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Kathrine Aagelen SeebergThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Birgitte SeipDepartment of Medicine, Vestfold Hospital Trust, Tønsberg, Norway.
Marius SvanevikThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Tone Gretland ValderhaugDepartment of Endocrinology, Division of Medicine, Akershus University Hospital HF, Oslo, Norway.
Dag HofsøThe Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function. METHODS AND ANALYSIS: Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery. ETHICS AND DISSEMINATION: The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings. TRIAL REGISTRATION NUMBER: NCT01778738;Pre-results.

Indexed as

Bariatric SurgeryDiabetes Mellitus, Type 2Insulin-Secreting CellsLaparoscopyObesity, MorbidEpidemiologic MethodsEquivalence Trials as TopicFemaleGastrectomyGastric BypassGlycated HemoglobinHumansMaleNorwayRandomized Controlled Trials as TopicTreatment OutcomeGlycated Hemoglobingastric bypassmorbid obesityrandomised controlled trialsleeve gastrectomytype 2 diabetesβ-cell function

Identifiers

PMID31167860
PMCPMC6561424

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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.