Wågen Hauge Jostein, Borgeraas Heidi, Birkeland Kåre Inge, Johnson Line Kristin, Hertel Jens Kristoffer, Hagen Milada, Gulseth Hanne Løvdal, Lindberg Morten, Lorentzen Jolanta, Seip Birgitte, Kolotkin Ronette L, Svanevik Marius, Valderhaug Tone Gretland, Sandbu Rune, Hjelmesæth Jøran, Hofsø Dag
Department of Endocrinology, Obesity, and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Department of Endocrinology, Obesity, and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway.
Lancet Diabetes Endocrinol. 2025 May;13(5):397-409. doi: 10.1016/S2213-8587(24)00396-6. Epub 2025 Apr 1.
For individuals with obesity and type 2 diabetes, weight loss improves insulin sensitivity and β-cell function and can induce remission of diabetes. However, the long-term comparative effectiveness of standard gastric bypass and sleeve gastrectomy on remission of type 2 diabetes remains unclear. We aimed to compare the effects of gastric bypass and sleeve gastrectomy on type 2 diabetes remission, weight loss, and cardiovascular risk factors 5 years after surgery.
We present a secondary analysis of a two-armed, single-centre, triple-blind, randomised controlled trial conducted at a public tertiary obesity centre in Norway. Adults (ie, age ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) by a computerised random number generator to laparoscopic gastric bypass or sleeve gastrectomy, with balanced block sizes of ten. Study personnel, participants, and the primary-outcome assessor were all masked to the allocation until 1 year after surgery, after which further follow-up was open label. Changes in key secondary outcomes, including type 2 diabetes remission, weight loss, and cardiovascular risk factors, were assessed 5 years after surgery. The trial procedure estimand assessed treatment effects in all randomised participants, with data collected after conversional surgery removed from analyses. The trial was registered with ClinicalTrials.gov (NCT01778738) and was completed in December, 2022.
Between Oct 15, 2012, and Sept 1, 2017, 319 patients were assessed for eligibility, resulting in 109 participants who were randomly assigned to gastric bypass (n=54) or sleeve gastrectomy (n=55). The baseline mean age was 47·7 years (SD 9·6), mean BMI 42·3 kg/m (SD 5·3), 72 (66%) were women, and 37 (34%) were men. 93 (85%) participants completed 5-year follow-up (47 [85%] in the sleeve gastrectomy group and 46 [85%] in the gastric bypass group). The proportions with remission of type 2 diabetes were higher after gastric bypass than after sleeve gastrectomy (HbA ≤6·0% 23 [50%] of 46 vs nine [20%] of 44, risk difference 29·5% [95% CI 10·8 to 48·3]; HbA <6·5% 29 [63%] vs 13 [30%], risk difference 33·5% [14·1 to 52·9]). Gastric bypass provided greater loss in bodyweight (mean 22·2% [95% CI 20·3 to 24·1] vs 17·2% [15·3 to 19·1], treatment difference 5·0% [2·4 to 7·7]) and lower LDL-cholesterol (treatment difference -0·5 mmol/L [-0·8 to -0·1]). The prevalence of erosive oesophagitis and Barrett's oesophagus was similar between groups, whereas pathological acid reflux occurred more frequently after sleeve gastrectomy (risk difference 51·1% [28·0 to 74·2]). More participants had symptomatic postprandial hypoglycaemia after gastric bypass than after sleeve gastrectomy (15 [28%] vs one [2%]).
Gastric bypass was superior to sleeve gastrectomy regarding long-term remission of type 2 diabetes, weight loss, and LDL cholesterol concentrations, at the expense of a higher frequency of symptomatic postprandial hypoglycaemia. These findings could inform clinical practice and future guidelines regarding the preferred surgical procedure in patients with type 2 diabetes.
Vestfold Hospital Trust.
For the Norwegian translation of the abstract see Supplementary Materials section.
对于肥胖和2型糖尿病患者,体重减轻可改善胰岛素敏感性和β细胞功能,并可促使糖尿病缓解。然而,标准胃旁路手术和袖状胃切除术对2型糖尿病缓解的长期比较效果仍不明确。我们旨在比较胃旁路手术和袖状胃切除术对术后5年2型糖尿病缓解、体重减轻及心血管危险因素的影响。
我们对在挪威一家公立三级肥胖中心进行的双臂、单中心、三盲随机对照试验进行了二次分析。将患有2型糖尿病和肥胖的成年人(即年龄≥18岁)通过计算机随机数字生成器随机分配(1:1)至腹腔镜胃旁路手术或袖状胃切除术,每组均衡分配10例。研究人员、参与者和主要结局评估者在术后1年内均对分组情况保密,之后的进一步随访为开放标签。在术后5年评估关键次要结局的变化,包括2型糖尿病缓解、体重减轻和心血管危险因素。试验程序估计值评估所有随机分配参与者的治疗效果,分析时剔除转流手术后收集的数据。该试验已在ClinicalTrials.gov注册(NCT01778738),并于2022年12月完成。
在2012年10月15日至2017年9月1日期间,对319例患者进行了资格评估,109例参与者被随机分配至胃旁路手术组(n = 54)或袖状胃切除术组(n = 55)。基线平均年龄为47.7岁(标准差9.6),平均BMI为42.3 kg/m²(标准差5.3),72例(66%)为女性,37例(34%)为男性。93例(85%)参与者完成了5年随访(袖状胃切除术组47例[85%],胃旁路手术组46例[85%])。胃旁路手术后2型糖尿病缓解的比例高于袖状胃切除术后(糖化血红蛋白≤6.0%:胃旁路手术组46例中的23例[50%],袖状胃切除术组44例中的9例[20%],风险差异29.5%[95%CI 10.8至48.3];糖化血红蛋白<6.5%:29例[63%]对13例[30%],风险差异33.5%[14.1至52.9])。胃旁路手术导致更大程度的体重减轻(平均22.2%[95%CI 2·03至24.1]对17.2%[15.3至19.1],治疗差异5.0%[2.4至7.7])和更低的低密度脂蛋白胆固醇水平(治疗差异-0.5 mmol/L[-0.8至-0.1])。两组间糜烂性食管炎和巴雷特食管的患病率相似,而袖状胃切除术后病理性胃酸反流更频繁发生(风险差异51.1%[28.0至74.2])。胃旁路手术后有症状的餐后低血糖患者比袖状胃切除术后更多(15例[28%]对1例[2%])。
在2型糖尿病的长期缓解、体重减轻和低密度脂蛋白胆固醇浓度方面,胃旁路手术优于袖状胃切除术,但代价是有症状的餐后低血糖发生率更高。这些发现可为2型糖尿病患者首选手术方式的临床实践和未来指南提供参考。
韦斯特福尔医院信托基金。
如需该摘要的挪威语翻译,请参阅补充材料部分。