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 s urg e ry in Tøns berg ( O seberg) study

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, Tor-Ivar Karlsen, Ronette L Kolotkin, Nils Petter Kvan, Morten Lindberg, Jolanta Lorentzen, Njord Nordstrand, Rune Sandbu, Kathrine Aagelen Seeberg, Birgitte Seip, Marius Svanevik, Tone Gretland Valderhaug, Dag Hofsø, 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, Tor-Ivar Karlsen, Ronette L Kolotkin, Nils Petter Kvan, Morten Lindberg, Jolanta Lorentzen, Njord Nordstrand, Rune Sandbu, Kathrine Aagelen Seeberg, Birgitte Seip, Marius Svanevik, Tone Gretland Valderhaug, Dag Hofsø

Abstract

Introduction: Bariatric 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.

Keywords: gastric bypass; morbid obesity; randomised controlled trial; sleeve gastrectomy; type 2 diabetes; β-cell function.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

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Figure 1
Flowchart.
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Figure 2
Timeline.

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