Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial.
Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial.
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DOI：
10.1001/jamasurg.2014.514
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发表时间：
2014-07
期刊：
影响因子：
16.9
通讯作者：
Goldfine, Allison B.
中科院分区：
文献类型：
--
作者：
Halperin, Florencia;Ding, Su-Ann;Simonson, Donald C.;Panosian, Jennifer;Goebel-Fabbri, Ann;Wewalka, Marlene;Hamdy, Osama;Abrahamson, Martin;Clancy, Kerri;Foster, Kathleen;Lautz, David;Vernon, Ashley;Goldfine, Allison B.
新的数据支持减肥手术作为2型糖尿病管理的治疗策略。测试进行更大规模多中心试验的方法的可行性，以确定Roux-en-Y胃旁路术（RYGB）手术与强化糖尿病医疗和体重管理（体重实现和强化治疗[为什么等待]）计划相比对2型糖尿病的长期影响。在学术医疗机构进行了为期1年的实用随机临床试验。参与者包括年龄在21至65岁之间的2型糖尿病患者，他们在研究前诊断超过1年;他们的身体质量指数为30至42（计算为体重（公斤）除以身高（米）的平方），血红蛋白A1 c（HbA 1c）大于或等于6.5%。所有参与者均接受降糖药物治疗。RYGB（n = 19）或Why WAIT（n = 19），包括12次每周一次的多学科小组生活方式，医疗和教育会议，此后每月随访。空腹血糖水平低于126 mg/dL且HbA 1c低于6.5%的患者比例、心脏代谢健康指标和患者报告的结局。1年时，RYGB后HbA 1c低于6.5%和空腹血糖低于126 mg/dL的患者比例高于Why WAIT（分别为58%和16%; P = 0.03）。其他结果，包括HbA 1c，体重，腰围，脂肪量，瘦体重，血压和甘油三酯水平，与为什么等待相比，RYGB后降低和高密度脂蛋白胆固醇增加更多。手术组心血管风险评分的改善更大。在基线时，参与者表现出中等偏低的自我报告的生活质量评分，反映了简表-36总，身体健康和心理健康，以及体重对生活质量的影响-Lite和糖尿病健康状况评分的问题领域。在1年时，两组之间的简表-36身心健康评分和糖尿病问题领域评分的改善没有显著差异。体重对生活质量的影响-与为什么等待相比，RYGB的Lite评分改善更多，并且与更大的体重减轻相关。在肥胖的2型糖尿病患者中，与药物治疗相比，RYGB产生更大的体重减轻和HbA 1c和心脏代谢风险因素的持续改善，1年以上的紧急差异。这两种治疗方法都能改善一般的生活质量指标，但RYGB在体重对生活质量的影响方面提供了更大的改善。这些差异可能有助于为肥胖2型糖尿病患者的糖尿病治疗决策和减肥策略提供信息，直到进行更大规模的随机试验。
Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A1c (HbA1c) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. At 1 year, the proportion of patients achieving HbA1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA1c, weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life–Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life–Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed.
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