Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial.
Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial.
复制标题
DOI：
10.1007/s00125-016-3903-x
复制
发表时间：
2016-05
期刊：
影响因子：
8.2
通讯作者：
Flum DR
中科院分区：
文献类型：
--
作者：
Cummings DE;Arterburn DE;Westbrook EO;Kuzma JN;Stewart SD;Chan CP;Bock SN;Landers JT;Kratz M;Foster-Schubert KE;Flum DR
越来越多的证据表明，Roux-en-Y胃分流术(RYGB)可以改善2型糖尿病，但需要比较手术和非手术治疗的随机试验。通过平行组随机对照试验(RCT)，我们比较了RYGB和强化生活方式和药物干预(ILMI)对2型糖尿病的影响，包括体重指数为35公斤/平方米的患者。通过使用共享的决策招募策略，针对综合社区卫生保健系统中的所有高危人群，我们筛选了1,808名符合纳入标准的成年人(年龄25-，患有2型糖尿病，体重指数30-45 kg/m2)。其中，43个是通过隐蔽的、计算机生成的随机分配，与RYGB或ILMI的比例为1：1。后者包括≥每周5天45分钟的有氧运动，营养师指导的减肥降糖饮食，以及为期1年的最佳糖尿病治疗。虽然治疗分配不可能是盲目的，但结果是由盲人裁判员决定的。主要结果是1年后糖尿病缓解(HbA1c和lt；6.0%[<；42.1 mm o l/m ol]，停用所有糖尿病药物)。23名志愿者被分配到RYGB，20名志愿者被分配到ILMI。在这些人中，11人在接受任何干预之前退出。因此，对RYGB组中的15人和IMLI组中的17人进行了为期一年的分析。除了RYGB组的糖尿病病程较长(11.4±4.8年vs6.8±5.2年，p=0.009)外，两组在所有基线特征上都是相同的。RYGB与ILMI治疗后1年的体重下降分别为25.8±14.5%和6.4±5.8%(p<；0.001)。ILMI运动计划的V̇O2max(P<；0.0001)增加了22±11%，而RYGB不变的V̇O2max没有变化。1年后，RYGB组的糖尿病缓解率为60.0%，ILMI组为5.9%(p=0.002)。RYGB治疗后1年的HbA1c下降幅度仅略大于ILMI：分别从7.7±1.0%(60.7 mm o l/m ol)降至6.4±1.6%(46.4 m o l/m ol)对7.3±0.9%(56.3 m o l/m o l)至6.9±1.3%(51.9 m o l/m o l)(p=0.04)；然而，这种下降发生在服用RYGB后糖尿病药物显著减少或不用药的情况下。未发生危及生命的并发症。与在随机试验中对手术进行测试的最严格的ILMI相比，RYGB在从知情的、基于人群的样本招募的轻度到中度肥胖患者中产生了更大的2型糖尿病缓解。临床试验.gov NCT01295229
Mounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m2. By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25–64, with type 2 diabetes and a BMI 30–45 kg/m2). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines). Twenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4±4.8 vs 6.8±5.2 years, p=0.009). Weight loss at 1 year was 25.8±14.5% vs 6.4±5.8% after RYGB vs ILMI, respectively (p<0.001). The ILMI exercise programme yielded a 22±11% increase in V̇O2max (p <0.0001), whereas V̇O2max after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p=0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7±1.0% (60.7 mmol/mol) to 6.4 ±1.6% (46.4 mmol/mol) vs 7.3±0.9% (56.3 mmol/mol) to 6.9±1.3% (51.9 mmol/mol), respectively (p=0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred. Compared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample. ClinicalTrials.gov NCT01295229