超重人群接受有和无减重手术的多学科糖尿病护理：一项随机对照试验。
Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.
机构信息
Centre for Obesity Research and Education (CORE), Monash University, Melbourne, Australia; Molecular Medicine Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, Melbourne, Australia.
Centre for Obesity Research and Education (CORE), Monash University, Melbourne, Australia.
出版信息
Lancet Diabetes Endocrinol. 2014 Jul;2(7):545-52. doi: 10.1016/S2213-8587(14)70066-X. Epub 2014 Apr 7.
BACKGROUND
Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese.
METHODS
We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246.
FINDINGS
51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band.
INTERPRETATION
When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile. Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population.
FUNDING
Monash University Centre for Obesity Research and Education and Allergan.
背景
减重手术可改善 2 型糖尿病肥胖患者的血糖水平，但对于超重但非肥胖的此类患者，其效果尚不确定。我们旨在确定腹腔镜可调节胃束带手术是否可以改善超重 2 型糖尿病患者的血糖控制。
方法
我们于 2009 年 11 月 1 日至 2013 年 6 月 30 日在澳大利亚墨尔本的一个中心进行了一项开放性、平行组、随机对照试验。年龄在 18-65 岁之间、患有 2 型糖尿病且 BMI 在 25-30kg/m2 之间的患者被随机分配（1:1），通过计算机生成的随机序列，接受多学科糖尿病护理加腹腔镜可调节胃束带手术或多学科糖尿病护理单独治疗。主要结局是随机分组后 2 年糖尿病缓解，定义为停止使用降血糖药物至少两天后，空腹血糖<7.0mmol/L，口服 75g 葡萄糖后 2h 血糖<11.1mmol/L。分析采用意向治疗。这项试验在澳大利亚和新西兰临床试验注册中心注册，编号为 ACTRN12609000286246。
结果
51 名患者被随机分配至多学科护理加胃束带组（n=25）或多学科护理组（n=26），其中分别有 23 名和 25 名参与者完成了 2 年的随访。多学科护理加胃束带组中有 12 名（52%）参与者和多学科护理组中仅有 2 名（8%）参与者达到糖尿病缓解（比例差异 0.44，95%CI 0.17-0.71；p=0.0012）。胃束带组有 1 名（4%）患者需要进行修订手术，另外 4 名（17%）患者因束带过度调整而总共发生 5 次食物不耐受事件。
解释
当与多学科护理联合使用时，腹腔镜可调节胃束带手术可改善超重 2 型糖尿病患者的血糖控制，且具有可接受的不良事件谱。腹腔镜可调节胃束带手术是该人群的合理治疗选择。
经费
莫纳什大学肥胖研究和教育中心和艾尔建公司。
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