袖状胃切除术与Roux-en-Y胃旁路术治疗2型糖尿病和病态肥胖：双盲随机临床试验方案
Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol.
作者信息
Murphy Rinki, Evennett Nicholas J, Clarke Michael G, Robinson Steven J, Humphreys Lee, Jones Bronwen, Kim David D, Cutfield Richard, Plank Lindsay D, Hammodat Hisham, Booth Michael W C
机构信息
Faculty of Medical and Health Sciences, Department of Medicine, University of Auckland, Auckland, New Zealand.
Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.
出版信息
BMJ Open. 2016 Jul 4;6(7):e011416. doi: 10.1136/bmjopen-2016-011416.
INTRODUCTION
Type 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6% (<42 mmol/mol) without the use of diabetes medication at 5 years.
METHODS AND ANALYSIS
Single-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20-55 years, T2D of at least 6 months duration and body mass index 35-65 kg/m(2) for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c<5.7% (39 mmol/mol) or HbA1c<6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings.
TRIAL REGISTRATION NUMBERS
ACTRN12611000751976, NCT01486680; Pre-results.
引言
2型糖尿病（T2D）合并肥胖的疾病负担日益加重。减重手术是使病态肥胖患者的T2D得到缓解的唯一有效疗法。目前尚不清楚两种最常用的减重手术，即腹腔镜袖状胃切除术（LSG）和腹腔镜Roux-en-Y胃旁路术（LRYGB），哪种对肥胖的T2D患者最为有效。本研究的主要目的是确定LSG或LRYGB在5年时不使用糖尿病药物的情况下使糖化血红蛋白（HbA1c）<6%（<42 mmol/mol）更为有效。
方法与分析
在新西兰进行的单中心、双盲（评估者和患者）、平行、随机临床试验（RCT），目标为106例患者。纳入标准包括年龄20 - 55岁、T2D病程至少6个月且体重指数35 - 65 kg/m²至少5年。按1:1随机分为LSG或LRYGB组，使用麻醉诱导后向手术医生披露的随机数字编码。术后代谢评估期间将采用标准药物调整方案。次要结局包括不使用糖尿病药物情况下达到HbA1c<5.7%（39 mmol/mol）或HbA1c<6.5%（48 mmol/mol）的比例、对比体重减轻情况、肥胖相关合并症、手术并发症、翻修率、死亡率、生活质量、焦虑和抑郁评分。探索性结局包括饱腹感、肠道激素和肠道微生物群的变化，以深入了解T2D缓解的潜在机制。
伦理与传播
已获得新西兰地区伦理委员会（NZ93405）的伦理批准，该委员会还对试验进行独立安全监测。研究于2011年9月开始。2014年10月完成招募。数据收集正在进行中。结果将在提交给同行评审期刊的稿件以及在国内和国际会议的报告中公布。
试验注册号
ACTRN12611000751976，NCT01486680；预结果。
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