Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.
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DOI:
10.1001/jamasurg.2015.1534
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发表时间:
2015-10
期刊:
影响因子:
16.9
通讯作者:
Jakicic JM
Jakicic JM
中科院分区:
医学1区
文献类型:
--
作者:
Courcoulas AP;Belle SH;Neiberg RH;Pierson SK;Eagleton JK;Kalarchian MA;DeLany JP;Lang W;Jakicic JM

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关于2型糖尿病(T2DM)减肥手术的作用和持久性的问题仍然存在。本研究比较了手术和非手术治疗后T2DM的缓解情况。美国匹兹堡大学医学中心的随机对照试验。在治疗61例肥胖T2DM患者3年后,对结果进行评估,这些患者被随机分为强化生活方式减肥干预1年,随后进行低生活方式减肥干预(LLLI) 2年,或手术治疗[Roux en Y胃旁路(RYGB)或腹腔镜可调节胃束带(LAGB)],随后在第2年和第3年进行LLLI。主要终点是糖尿病部分缓解和完全缓解,次要终点包括糖尿病药物和体重变化。26人(43%)的身体质量指数<35kg/m2, 50人(82%)是女性,13人(21%)是非裔美国人。平均(SD)值为体重100.5 (13.7)kg,年龄47.3(6.6)岁,糖化血红蛋白水平7.8%(1.9%),空腹血糖171.3 (72.5)mg/dL。RYGB组40% (n=8), LAGB组29% (n=6),无LWLI组(p=0.0037)达到部分或完全T2DM缓解。手术组糖尿病药物的使用比单纯生活方式组减少得更多;65%的RYGB患者、33%的LAGB患者和0%的LWLI患者从基线时使用胰岛素或口服药物到第3年不使用药物(p<0.0001)。RYGB组3年平均体重(SE)下降幅度最大,为25.0%(2.0),其次为LAGB组15.0%(2.0),生活方式组5.7% (2.4)(p<0.01)。在患有2型糖尿病的肥胖参与者中,减肥手术加2年的辅助LLLI比单独的生活方式干预导致更多的疾病缓解。
Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). This study compared the remission of T2DM following surgical and non-surgical treatments. Randomized Controlled Trial University of Pittsburgh Medical Center, in the United States. Outcomes were assessed 3 years after treating 61 obese participants with T2DM who were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a lower lifestyle weight loss intervention (LLLI) for 2 years or surgical treatments [Roux en Y gastric bypass (RYGB) or Laparoscopic adjustable gastric banding (LAGB)] followed by LLLI in years 2 and 3. Primary endpoints were partial and complete diabetes remission and secondary endpoints included diabetes medications and weight change. Body mass index was <35kg/m2 for 26 (43%) participants, 50 (82%) were women, and 13 (21%) African American. Mean (SD) values for weight were 100.5 (13.7) kg, age 47.3 (6.6) years, hemoglobin A1c level 7.8% (1.9%), and fasting plasma glucose 171.3 (72.5) mg/dL. Partial or complete T2DM remission was achieved by 40% (n=8) of RYGB, 29% (n=6) of LAGB, and no LWLI participants (p=0.0037). The use of diabetes medications was reduced more in the surgical groups than the lifestyle alone group; with 65% of RYGB, 33% of LAGB, and 0% of LWLI going from using insulin or oral medication at baseline to no medication at year 3 (p<0.0001). Mean (SE) reductions in percent body weight at 3 years was the greatest after RYGB 25.0% (2.0), followed by LAGB 15.0% (2.0) and lifestyle treatment 5.7% (2.4) (p<0.01). Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive LLLI resulted in more disease remission than did lifestyle intervention alone.