Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.
Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.
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DOI：
10.1001/jama.2013.5835
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发表时间：
2013-06-05
影响因子：
120.7
通讯作者：
Bantle, John P.
中科院分区：
文献类型：
--
作者：
Ikramuddin, Sayeed;Korner, Judith;Lee, Wei-Jei;Connett, John E.;Inabnet, William B., III;Billington, Charles J.;Thomas, Avis J.;Leslie, Daniel B.;Chong, Keong;Jeffery, Robert W.;Ahmed, Leaque;Vella, Adrian;Chuang, Lee-Ming;Bessler, Marc;Sarr, Michael G.;Swain, James M.;Laqua, Patricia;Jensen, Michael D.;Bantle, John P.
糖尿病的指导性护理要求控制血糖、血压和胆固醇（复合目标）。大多数接受药物治疗的患者都达不到这一目标。确定Roux-en-Y胃旁路术（RYGB）与生活方式改变和强化医疗管理（LS/IMM）联合使用以控制所有3个终点的有效性和安全性。120例受试者的双臂非盲随机临床试验。在12个月时评估复合结局的主要终点。该研究于2008年4月开始，并于2012年12月完成了对所有参与者的一年随访。美国和台湾的四家学术教学医院，涉及五名手术外科医生。糖尿病手术研究（DSS）的入选标准包括HbA 1c ≥ 8.0%，BMI 30.0-39.9 kg/m2，诊断和治疗2型糖尿病至少6个月，刺激C肽> 1.0 ng/ml。所有患者都接受了Look AHEAD研究后的生活方式干预。根据方案处方治疗高血糖、高血压和血脂异常的药物。RYGB技术标准化。达到复合目标：HbA 1c <7.0%，LDL-C < 100 mg/dl，SBP < 130 mmHg。120名受试者以相等的概率随机分为LS/IMM或RYGB（每组60名）。两组的基线特征相似。平均BMI为34.6 kg/m2（95% CI 29.2 - 40.8 kg/m2），71例（59%; 95% CI 50%-68%）受试者BMI < 35 kg/m2，平均HbA 1c为9.6%（95% CI 9.4%-9.8%）。12个月时，随访率为95%，LS/IMM组中11例（19%）和RYGB组中28例（49%）达到主要终点（OR = 4.8，95% CI 1.9 - 11.6）。RYGB参与者需要的药物比LS/IMM少3.1（4.8 vs 1.7，95% CI -3.6至-2.3）。体重减轻为7.9% LS/IMM vs. 26.1% RYGB（差异18.2% 95% CI 14.2%-20.7%）。回归分析表明，达到复合终点主要归因于体重减轻。RYGB组有22起严重不良事件，包括1起心血管事件，LS/IMM组有15起。RYGB组有4例围手术期并发症和6例术后晚期并发症。铁、维生素B12和白蛋白的营养缺乏在RYGB中更常见。在轻度至中度肥胖的2型糖尿病患者中，将RYGB添加到LS/IMM中导致实现复合治疗目标的可能性更大。RYGB参与者需要更少的药物，但并发症更多。
Guideline directed care for diabetes calls for control of glycemia, blood pressure and cholesterol (composite goal). Most patients treated medically do not reach this goal. Determine the efficacy and safety of Roux-en-Y gastric bypass (RYGB) added to lifestyle modification and intensive medical management (LS/IMM) to achieve control of all 3 endpoints. Two-arm unblinded randomized clinical trial with 120 participants. The primary endpoint of the composite outcome was assessed at 12 months. The study began in April 2008 and completed one year follow-up in all participants in December 2012. Four academic teaching hospitals in the U.S. and Taiwan, involving five operating surgeons. Inclusion criteria for the Diabetes Surgery Study (DSS) included HbA1c ≥ 8.0%, BMI 30.0-39.9 kg/m2, diagnosis and treatment of type 2 diabetes for at least six months, and stimulated C peptide > 1.0 ng/ml. All patients received lifestyle intervention modeled after the Look AHEAD study. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol. RYGB techniques were standardized. Attainment of a composite goal: HbA1c < 7.0%, LDL-C < 100 mg/dl, and SBP < 130 mmHg. One hundred and twenty participants were randomized with equal probability into LS/IMM or RYGB (60 in each group). Baseline characteristics were similar between groups. Mean BMI was 34.6 kg/m2 (95% CI 29.2 to 40.8 kg/m2) with 71 (59%; 95% CI 50% to 68%) participants having BMI < 35 kg/m2, and mean HbA1c was 9.6% (95% CI 9.4% to 9.8%). At 12 months the followup rate was 95%, and 11 (19%) in the LS/IMM group and 28 (49%) in the RYGB group achieved the primary endpoint (OR = 4.8, 95% CI 1.9 to 11.6). RYGB participants required 3.1 fewer medications than LS/IMM (4.8 versus 1.7, 95% CI -3.6 to -2.3). Weight loss was 7.9% LS/IMM vs. 26.1% RYGB (difference 18.2% 95% CI 14.2% to 20.7%). Regression analyses indicate that achieving the composite endpoint was primarily attributable to weight loss. There were 22 serious adverse events in the RYGB group, including one cardiovascular event, and 15 in the LS/IMM group. There were 4 peri-operative complications and 6 late postoperative complications in the RYGB group. Nutritional deficiency of iron, vitamin B12 and albumin were observed more frequently with RYGB. In mild to moderately obese patients with type 2 diabetes addition of RYGB to LS/IMM resulted in greater likelihood of achieving the composite treatment goal. RYGB participants required fewer medications but had more complications.
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影响因子：
3.1
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