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.

Autor:	Borgeraas H; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway., Hjelmesæth J; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Birkeland KI; Department of Transplantation, Oslo University Hospital, Oslo, Norway., Fatima F; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Grimnes JO; Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway., Gulseth HL; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Halvorsen E; Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway., Hertel JK; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway., Hillestad TOW; Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway., Johnson LK; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway., Karlsen TI; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Health and Nursing Sciences, University of Agder, Kristiansand, Norway., Kolotkin RL; Quality of Life Consulting, PLLC, Durham, North Carolina, USA.; Department of Family Medicine and Community Health, Duke University School of Medicine, Durham, North Carolina, USA., Kvan NP; Department of Radiology, Vestfold Hospital Trust, Tønsberg, Norway., Lindberg M; Department of Biochemistry, Vestfold Hospital Trust, Tønsberg, Norway., Lorentzen J; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Nordstrand N; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway., Sandbu R; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway., Seeberg KA; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Seip B; Department of Medicine, Vestfold Hospital Trust, Tønsberg, Norway., Svanevik M; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Institute of Clinical Medicine, Oslo University Hospital, Oslo, Norway., Valderhaug TG; Department of Endocrinology, Division of Medicine, Akershus University Hospital HF, Oslo, Norway., Hofsø D; The Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2019 Jun 04; Vol. 9 (6), pp. e024573. Date of Electronic Publication: 2019 Jun 04.
DOI:	10.1136/bmjopen-2018-024573
Abstrakt:	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. Competing Interests: 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.)
Databáze:	MEDLINE
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