腹腔镜可调节胃束带联合利拉鲁肽治疗肥胖合并 2 型糖尿病的疗效（GLIDE）：一项先导性随机安慰剂对照试验。
Laparoscopic adjustable gastric banding with liraglutide in adults with obesity and type 2 diabetes (GLIDE): a pilot randomised placebo controlled trial.
机构信息
Department of Diabetes and Endocrinology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Department of Endocrinology, King's College Hospital NHS Foundation Trust, London, UK.
出版信息
Int J Obes (Lond). 2023 Nov;47(11):1132-1142. doi: 10.1038/s41366-023-01368-4. Epub 2023 Sep 11.
INTRODUCTION
Obesity drives type 2 diabetes (T2DM) development. Laparoscopic adjustable gastric banding (LAGB) has lower weight reduction than other bariatric procedures. Liraglutide, a GLP-1 receptor agonist, improves weight and glycaemic control in patients with T2DM. This study aimed to determine the efficacy and safety of liraglutide 1.8 mg in participants undergoing LAGB.
METHODS
GLIDE, a pilot randomised, double-blind, placebo-controlled trial, evaluated LAGB with either liraglutide 1.8 mg or placebo in participants with T2DM and obesity. Participants were randomised (1:1) to 6-months therapy post-LAGB, with further 6 months off-treatment follow-up. The primary outcome was change in HbA1c from randomisation to the end of treatment, secondary outcomes included body weight change. A sample size of 58 (29 per group) had 80% power to detect a 0.6% difference in HbA1c between groups.
RESULTS
Twenty-seven participants were randomised to liraglutide (n = 13) or placebo (n = 14). Multivariate analysis showed no difference between placebo and liraglutide arms in HbA1c at 6 months (HbA1c:0.2 mmol/mol, -11.3, 11.6, p = 0.98) however, at 12 months HbA1c was significantly higher in the liraglutide arm (HbA1c:10.9 mmol/mol, 1.1, 20.6, p = 0.032). There was no difference between arms in weight at 6 months (BW:2.0 kg, -4.2, 8.1, p = 0.50), however, at 12 months weight was significantly higher in the liraglutide arm (BW:8.2 kg, 1.6, 14.9, p = 0.02). There were no significant differences in adverse events between groups.
CONCLUSIONS
Our pilot data suggest no additional improvement in glycaemic control or BW with LAGB and liraglutide therapy. However, this trial was significantly underpowered to detect a significant change in the primary or secondary outcomes. Further trials are needed to investigate whether GLP-1 agonists, and particularly with more effective weekly agents (i.e. semaglutide or tirzepatide), are of benefit following metabolic surgery.
CLINICAL TRIAL REGISTRATION
EudraCT number 2015-005402-11.
简介
肥胖会导致 2 型糖尿病（T2DM）的发生。腹腔镜可调节胃束带术（LAGB）的减重效果不如其他减重手术。利拉鲁肽是一种 GLP-1 受体激动剂，可改善 T2DM 患者的体重和血糖控制。本研究旨在确定利拉鲁肽 1.8mg 在接受 LAGB 的患者中的疗效和安全性。
方法
GLIDE 是一项先导性随机、双盲、安慰剂对照试验，评估了 LAGB 联合利拉鲁肽 1.8mg 或安慰剂治疗 T2DM 合并肥胖症患者的疗效。参与者按 1:1 随机分组，在 LAGB 术后进行 6 个月的治疗，随后进行 6 个月的停药随访。主要结局为随机分组至治疗结束时的 HbA1c 变化，次要结局包括体重变化。研究纳入了 58 例（每组 29 例）参与者，具有 80%的效能来检测两组之间 HbA1c 差异 0.6%。
结果
27 例参与者被随机分配至利拉鲁肽组（n=13）或安慰剂组（n=14）。多变量分析显示，6 个月时利拉鲁肽组与安慰剂组的 HbA1c 无差异（HbA1c：0.2mmol/mol，-11.3，11.6，p=0.98），但 12 个月时利拉鲁肽组的 HbA1c 显著升高（HbA1c：10.9mmol/mol，1.1，20.6，p=0.032）。6 个月时两组间体重无差异（BW：2.0kg，-4.2，8.1，p=0.50），但 12 个月时利拉鲁肽组体重显著升高（BW：8.2kg，1.6，14.9，p=0.02）。两组间不良反应无显著差异。
结论
本研究的初步数据表明，LAGB 联合利拉鲁肽治疗并未带来血糖控制或体重的额外改善。然而，本试验在检测主要或次要结局方面的效能显著不足。需要进一步的试验来研究 GLP-1 激动剂，特别是更有效的每周制剂（如司美格鲁肽或替西帕肽）在代谢手术后是否有益。
临床试验注册
EudraCT 编号 2015-005402-11。
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