Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.
Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.
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DOI：
10.1001/jamasurg.2014.467
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发表时间：
2014-07
期刊：
影响因子：
16.9
通讯作者：
Jakicic, John M.
中科院分区：
文献类型：
--
作者：
Courcoulas, Anita P.;Goodpaster, Bret H.;Eagleton, Jessie K.;Belle, Steven H.;Kalarchian, Melissa A.;Lang, Wei;Toledo, Frederico G. S.;Jakicic, John M.
解决关于糖尿病患者减肥手术作用的未解之谜。确定一项随机对照试验（RCT）的可行性，并比较1级和2级肥胖患者治疗2型糖尿病的减肥手术和有组织的减肥计划的初步结果。一项为期12个月，单中心的3组随机对照试验，包括69名年龄25-55岁，BMI 30-40, 2型糖尿病患者。两种外科手术；Roux-en-Y胃旁路术（RYGB），腹腔镜可调节胃带（LAGB）和强化生活方式减肥干预（LWLI）。意向治疗（ITT）队列的主要结果是通过体重减轻和血糖控制改善来衡量可行性和有效性。筛选了667名潜在参与者，其中69名（10.3%）被随机分配，30名（43.5%）为1级肥胖。平均年龄47.3±6.4岁，女性81%，平均糖化血红蛋白7.9±2.0。随机分组后，7名（10%）参与者拒绝接受分配的干预措施（3名RYGB， 1名LAGB， 3名LWLI）， 1名RYGB因吸烟而被排除。20名受试者进行了RYGB， 21名进行了LAGB， 20名进行了LWLI， 12个月的保留率分别为90%，86%和70%。在ITT队列中，与LAGB和LWLI相比，RYGB参与者的体重下降幅度最大，平均体重分别较基线下降27%、17%和10% （p< 0.0001）。RYGB组糖尿病部分/完全缓解率为50%/17%，LAGB组为27%/23%，LWLI组为0%/0% （p= 0.0005 / 0.047，部分/完全），两组患者用药均显著减少。无死亡，3例严重不良事件；1例RYGB溃疡内科治疗，2例LAGB因脱水再次住院。这项研究强调了成功完成BMI为30-40 kg/m2的糖尿病和肥胖治疗的大型随机对照试验的几个潜在挑战，包括招募和随机分配患者进行手术和非手术干预的困难。初步结果显示，RYGB是最有效的治疗方法，其次是LAGB，在一年的体重减轻和糖尿病结局。
Address unanswered questions about the role of bariatric surgery for people with diabetes. Determine feasibility of a randomized controlled trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating type 2 diabetes mellitus in grade 1 and 2 obese participants. A 12-month, 3-arm RCT at a single center including 69 participants age 25–55 years, BMI 30–40 with type 2 diabetes. Two surgical procedures; Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric band (LAGB) and an intensive lifestyle weight loss intervention (LWLI). Primary outcomes in the intention to treat (ITT) cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control. 667 potential participants were screened of whom 69 (10.3%) were randomized, 30 (43.5%) with grade 1 obesity. Mean age was 47.3±6.4 years, 81% were women, and mean glycated hemoglobin was 7.9±2.0. After randomization, 7 (10%) participants refused to undergo their allocated intervention (3 RYGB, 1 LAGB, 3 LWLI) and 1 RYGB was excluded for current smoking. Twenty subjects underwent RYGB, 21 LAGB, and 20 LWLI with retention at 12 months of 90%, 86%, and 70%, respectively. In the ITT cohort with multiple imputation for missing data, RYGB participants had the greatest weight loss compared to LAGB and LWLI with average weight loss of 27%, 17%, 10% from baseline, respectively (p<.0001). Partial/complete remission of diabetes was 50%/17% in RYGB, 27%/23% in LAGB and 0%/0% in LWLI (p=.0005/.047, partial/complete) and there were significant reductions in medication usage in both surgical groups. There were no deaths and 3 serious adverse events; 1 RYGB ulcer was treated medically and 2 LAGB were re-hospitalized for dehydration. This study highlights several potential challenges to successfully completing a larger RCT for diabetes and obesity treatment in those with BMI 30–40 kg/m2, including the difficulties associated with recruiting and randomizing patients to surgical versus non-surgical interventions. Preliminary results show that RYGB was the most effective treatment followed by LAGB for both weight loss and diabetes outcomes at one year.
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影响因子：
120.7
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.
通讯作者：
Bantle, John P.
DOI：
10.1056/nejmoa1200225
发表时间：
2012-04-26
期刊：
The New England journal of medicine
影响因子：
--
作者：
Schauer PR;Kashyap SR;Wolski K;Brethauer SA;Kirwan JP;Pothier CE;Thomas S;Abood B;Nissen SE;Bhatt DL
通讯作者：
Bhatt DL
影响因子：
9
作者：
PORIES, WJ;SWANSON, MS;DOHM, L
通讯作者：
DOHM, L
影响因子：
158.5
作者：
Mingrone, Geltrude;Panunzi, Simona;Rubino, Francesco
通讯作者：
Rubino, Francesco
减肥手术（实验室）的纵向评估：24个月的保留策略和结果。
DOI：
10.1016/j.soard.2013.02.012
发表时间：
2013-07
期刊：
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery
影响因子：
--
作者：
Gourash WF;Ebel F;Lancaster K;Adeniji A;Koozer Iacono L;Eagleton JK;MacDougall A;Cassady C;Ericson H;Pories W;Wolfe BM;Belle SH;LABS Consortium Retention Writing Group
通讯作者：
LABS Consortium Retention Writing Group