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 analysisSingle-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 disseminationThe 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 numberNCT01778738;Pre-results.
Context
Bariatric surgery, particularly Roux-en-Y gastric bypass (RYGB), is associated with increased risk of osteoporotic fractures. It is unknown whether RYGB or sleeve gastrectomy (SG) have different effects on bone health.
Objective
To compare changes in bone mineral density and markers of bone turnover one year after SG and RYGB.
Design, Setting, Patients, and Interventions
Randomized, triple-blind, single-center trial at a tertiary care center in Norway. Primary outcome was diabetes remission. Patients with severe obesity and type 2 diabetes were randomized and allocated (1:1) to SG or RYGB.
Main Outcome Measures
Changes in areal bone mineral density (aBMD) and bone turnover markers.
Results
Femoral neck, total hip, and lumbar spine aBMD, but not total body aBMD, decreased significantly more after RYGB (n=44) than after SG (n=48) [mean (95% CI) between group differences -2.8 % (-0.8 to -4.7), -3.0 % (-0.9 to -5.0), -4.2 % (-2.1 to -6.4), and -0.5 % (0.6 to -1.6), respectively]. The increase in procollagen type 1 N-terminal propeptide (P1NP) and C-telopeptide of type I collagen (CTX-1) were approximately 100% higher after RYGB than after SG, (both time x group, P<0.001). The changes in femoral neck, total hip and lumbar spine aBMDs and the changes in P1NP and CTX-1 were independently associated with the surgical procedure (all P<0.05) and not weight change.
Conclusions
RYGB was associated with greater reduction in aBMD and greater increase in bone turnover markers compared with SG. This finding could suggest greater skeletal fragility after RYGB.
The finding of reduced regional cerebral blood flow in patients with primary hyperparathyroidism followed by significant improvement after operation might influence the case for surgical treatment.
Cardiac uptake of bone scintigraphic agents is associated with high pulmonary uptake. This may be a sign of pulmonary involvement which may give extraosseous bone tracer uptake its own importance and DPD a new role.
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