Department of Surgery, Bariatric Surgery Clinic, Rabin Medical Center, Petach Tikva, Israel.
Diabetologia. 2013 Sep;56(9):1914-8. doi: 10.1007/s00125-013-2965-2. Epub 2013 Jun 14.
AIMS/HYPOTHESIS: Bariatric surgery is gaining acceptance as a 'metabolic surgical intervention' for patients with type 2 diabetes. The optimal form of surgery and the mechanism of action of these procedures are much debated. We compared two bariatric procedures for obese patients with type 2 diabetes and evaluated their effects on HbA1c and glucose tolerance.
We performed a parallel un-blinded randomised trial of Roux-en-Y gastric bypass (RYGB) vs sleeve gastrectomy (SG) in 41 obese patients with type 2 diabetes, who were bariatric surgery candidates attending the obesity clinic. HbA1c, body composition and glucose tolerance were evaluated at baseline, and at 3 and 12 months.
Of the 41 patients, 37 completed the follow-up (19 RYGB, 18 SG). Both groups had similar baseline anthropometric and biochemical measures, and showed comparable weight loss and fat:fat-free mass ratio changes at 12 months. A similar normalisation of HbA1c levels was observed as early as 3 months post-surgery (6.37 ± 0.71% vs 6.23 ± 0.69% for RYGB vs SG respectively, p < 0.001 in both groups for baseline vs follow-up).
CONCLUSIONS/INTERPRETATION: In this study, RYGB did not have a superior effect in comparison to SG with regard to HbA1c levels or weight loss during 12 months of follow-up.
ClinicalTrials.gov NCT00667706.
This work was supported by grant no. 3-000-8480 from the Israel Ministry of Health Chief Scientist, the Stephen Morse Diabetes Research Foundation and by Johnson & Johnson.
目的/假设:减重手术作为 2 型糖尿病患者的“代谢手术干预”越来越被认可。手术的最佳形式和这些手术的作用机制仍存在很大争议。我们比较了两种肥胖合并 2 型糖尿病患者的减重手术方式,并评估了它们对糖化血红蛋白(HbA1c)和葡萄糖耐量的影响。
我们对 41 名肥胖合并 2 型糖尿病且符合减重手术条件的患者进行了一项平行、非盲、随机试验,比较了 Roux-en-Y 胃旁路术(RYGB)与袖状胃切除术(SG)的效果。在基线、术后 3 个月和 12 个月时评估 HbA1c、人体成分和葡萄糖耐量。
41 名患者中,37 名完成了随访(RYGB19 例,SG18 例)。两组患者的基线人体测量学和生化指标相似,术后 12 个月体重减轻和脂肪与去脂体重比值的变化也相似。术后 3 个月即可观察到 HbA1c 水平的类似正常化(RYGB 组为 6.37±0.71%,SG 组为 6.23±0.69%,两组基线与随访相比均<0.001)。
结论/解释:在这项研究中,RYGB 在 12 个月的随访期间,HbA1c 水平或体重减轻方面与 SG 相比没有优势。
ClinicalTrials.gov NCT00667706。
这项工作得到了以色列卫生部首席科学家、斯蒂芬·莫尔斯糖尿病研究基金会和强生公司资助的 3-000-8480 号拨款的支持。