*Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH †Center for Bariatric Surgery, McGill University, Montreal, QC, Canada ‡Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH §Hospital Clínic Universitari, Barcelona, Spain ¶Department of Surgery, University Putra Malaysia, Selangor, Malaysia ||Department of Surgery, Khon Kaen University, Khon Kaen, Thailand **Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA ††Endocrine and Metabolic Institute, Cleveland Clinic, Cleveland, OH ‡‡CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Madrid, Spain.
Ann Surg. 2017 Oct;266(4):650-657. doi: 10.1097/SLA.0000000000002407.
To construct and validate a scoring system for evidence-based selection of bariatric and metabolic surgery procedures according to severity of type 2 diabetes (T2DM).
Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM.
A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005-2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied.
At median postoperative follow-up of 7 years (range 5-12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ≤25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional β-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided.
This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.
根据 2 型糖尿病(T2DM)的严重程度,构建并验证一种用于选择减重代谢手术的循证评分系统。
在美国,接受减重代谢手术的 T2DM 患者中,95%以上的患者接受了 Roux-en-Y 胃旁路术(RYGB)和袖状胃切除术(SG)。迄今为止,尚无基于 T2DM 患者长期血糖控制的模型来指导手术选择。
对在美国一家学术中心接受 RYGB 和 SG 的 659 例 T2DM 患者进行了分析,以生成该模型。验证数据集由西班牙一家学术中心的 241 例患者组成,该中心采用了类似的标准。
在中位术后 7 年(5-12 年)的随访中,RYGB 术后糖尿病缓解(HbA1C<6.5%,停药)率为 49%,SG 术后为 28%(P<0.001)。4 个独立的长期缓解预测因素,包括术前 T2DM 病程(P<0.0001)、术前糖尿病药物种类(P<0.0001)、胰岛素使用(P=0.002)和血糖控制(HbA1C<7%)(P=0.002),用于使用列线图开发个体化代谢手术(IMS)评分。然后,根据 IMS 评分将患者分为 3 个糖尿病严重程度阶段。在轻度 T2DM(IMS 评分≤25)中,两种手术均显著改善了 T2DM。在重度 T2DM(IMS 评分>95)中,当临床特征提示功能性β细胞储备有限时,两种手术对糖尿病缓解的疗效均较低。然而,存在一个中间组,RYGB 显著优于 SG,这可能与它更显著的神经激素作用有关。研究结果在外部得到了验证,并为每个严重程度阶段提供了手术推荐。
这是报道的最大队列(n=900),具有长期术后血糖随访,首次将 T2DM 分为 3 个经过验证的严重程度阶段,用于循证手术选择。