Dixon John B, O'Brien Paul E, Playfair Julie, Chapman Leon, Schachter Linda M, Skinner Stewart, Proietto Joseph, Bailey Michael, Anderson Margaret
Centre for Obesity Research and Education, Monash University Medical School, The Alfred Hospital, Melbourne, Victoria, Australia.
JAMA. 2008 Jan 23;299(3):316-23. doi: 10.1001/jama.299.3.316.
Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes.
To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control.
DESIGN, SETTING, AND PARTICIPANTS: Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40) with recently diagnosed (<2 years) type 2 diabetes.
Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care.
Remission of type 2 diabetes (fasting glucose level <126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat.
Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R2 = 0.46, P < .001) and lower baseline HbA1c levels (combined R2 = 0.52, P < .001). There were no serious complications in either group.
Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.
actr.org Identifier: ACTRN012605000159651.
观察性研究表明，手术诱导的体重减轻可能是2型糖尿病的有效治疗方法。
确定与传统的减肥和糖尿病控制方法相比，手术诱导的体重减轻是否能带来更好的血糖控制，以及减少对糖尿病药物的需求。
设计、地点和参与者：2002年12月至2006年12月在澳大利亚大学肥胖研究中心进行的非盲随机对照试验，通过社区招募进入既定治疗项目。参与者为60名肥胖患者（BMI>30且<40），近期诊断为（<2年）2型糖尿病。
以通过生活方式改变实现减肥为重点的传统糖尿病治疗与腹腔镜可调节胃束带术加传统糖尿病护理。
2型糖尿病缓解（空腹血糖水平<126mg/dL[7.0mmol/L]且糖化血红蛋白[HbA1c]值<6.2%，同时未接受降糖治疗）。次要指标包括体重和代谢综合征的组成部分。分析采用意向性分析。
60名入选患者中，55名（92%）完成了2年随访。手术组22名（73%）实现2型糖尿病缓解，传统治疗组4名（13%）实现缓解。手术组缓解的相对风险为5.5（95%置信区间，2.2 - 14.0）。2年时，手术组和传统治疗组体重平均（标准差）分别减轻20.7%（8.6%）和1.7%（5.2%）（P <.001）。2型糖尿病缓解与体重减轻（R2 = 0.46，P <.001）和较低的基线HbA1c水平（合并R2 = 0.52，P <.001）相关。两组均无严重并发症。
随机接受手术治疗的参与者通过更大程度的体重减轻更有可能实现2型糖尿病缓解。这些结果需要在更大、更多样化的人群中得到证实，并评估其长期疗效。
actr.org标识符：ACTRN012605000159651。
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