Bariatric surgery vs. advanced practice medical management in the treatment of type 2 diabetes mellitus: rationale and design of the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently trial (STAMPEDE)
Bariatric surgery vs. advanced practice medical management in the treatment of type 2 diabetes mellitus: rationale and design of the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently trial (STAMPEDE)
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DOI：
10.1111/j.1463-1326.2009.01172.x
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发表时间：
2010-05-01
影响因子：
5.8
通讯作者：
Schauer, Philip R.
中科院分区：
文献类型：
--
作者：
Kashyap, Sangeeta R.;Bhatt, Deepak L.;Schauer, Philip R.
肥胖和 2 型糖尿病 (T2DM) 密切相关，是全世界最常见的两种慢性衰弱性疾病。减肥手术（减肥手术）可显着改善 T2DM，但缺乏直接比较手术和药物治疗效果的随机试验。手术治疗和药物有效根除糖尿病 (STAMPEDE) 试验旨在评估仅涉及胃限制（腹腔镜袖状胃切除术）和胃绕道术 (Roux-en-Y) 两种减肥手术对 BMI 为 27-42 kg/m2 的中度肥胖 T2DM 患者进行先进药物治疗的效果。这项单中心、前瞻性、随机对照试验将招募 150 名受试者进行跟踪。主要终点是 1 年时 T2DM 的生化缓解率（以 HbA1c < 6% 衡量）。还将比较该研究三个组之间的安全性和不良事件发生率。
Obesity and Type 2 diabetes mellitus (T2DM) are closely interrelated, and are two of the most common chronic, debilitating diseases worldwide. Surgical approaches to weight loss (bariatric surgery) result in marked improvement of T2DM, however randomized trials directly comparing the efficacy of surgical and medical approaches are lacking. The Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial was designed to evaluate the efficacy of two bariatric surgery procedures involving gastric restriction only (laparascopic sleeve gastrectomy) and gastric bypass (Roux-en-Y) to advanced medical therapy in patients with T2DM with modest obesity with BMI of 27-42 kg/m2. This single site, prospective, randomized controlled trial will enroll 150 subjects who will be followed. The primary end point will be the rate of biochemical resolution of T2DM at 1 year as measured by HbA1c < 6%. The safety and adverse event rates will also be compared between the three arms of the study.