SIB试验的设计和原理:赛马鲁肽与安慰剂对2型糖尿病肠道屏障功能的随机平行比较。

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
ACS Applied Electronic Materials Pub Date : 2023-10-29 eCollection Date: 2023-01-01 DOI:10.1177/20420188231207348
Steven Rella, Joseph Onyiah, Chelsea Baker, Vatsala Singh, Andrew Her, Neda Rasouli
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引用次数: 0

摘要

目的:描述SIB试验的原理和设计。SIB试验是一项干预性临床试验,旨在检验每周皮下注射一次西格鲁肽可以改善2型糖尿病(T2D)和肥胖参与者的肠道通透性和减少全身炎症的假设。方法:SIB(NCT04979130)是一项由研究者发起的单中心随机、双盲、安慰剂对照临床研究,正在科罗拉多大学安舒茨医学院进行。这项新试验的主要目的是检验这样一种假设,即每周皮下注射一次塞米鲁肽可以改善T2D和肥胖参与者的肠道通透性并减少全身炎症。符合条件的参与者被诊断为2型糖尿病,体重指数升高,并有全身炎症的证据。参与者被1:1随机分配给皮下注射赛马鲁肽或安慰剂。在基线、研究中期和研究结束时,对参与者的肠道通透性和炎症标志物进行评估。疗效评估基于以下分析:乳果糖:甘露醇比率测试、血清脂多糖结合蛋白(LBP)、粪便钙卫蛋白、炎症生物标志物(IL-6、TNF、IL-1、IL-8、hs-CRP)和HbA1c。所有参加试验的参与者在收到有关试验的书面和口头信息后,都提供了书面知情同意书。根据美国食品药品监督管理局的标签使用和密切监测不良事件,将使用赛马鲁肽的风险降至最低。讨论:SIB是第一项研究GLP-1受体激动剂对人类肠道通透性的影响的研究,并将提供关于其在T2D和肥胖情况下对全身炎症和肠道通透性影响的重要数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Design and rationale for the SIB trial: a randomized parallel comparison of semaglutide <i>versus</i> placebo on intestinal barrier function in type 2 diabetes mellitus.

Design and rationale for the SIB trial: a randomized parallel comparison of semaglutide <i>versus</i> placebo on intestinal barrier function in type 2 diabetes mellitus.

Design and rationale for the SIB trial: a randomized parallel comparison of semaglutide <i>versus</i> placebo on intestinal barrier function in type 2 diabetes mellitus.

Design and rationale for the SIB trial: a randomized parallel comparison of semaglutide versus placebo on intestinal barrier function in type 2 diabetes mellitus.

Objective: To describe the rationale and design of the SIB trial, an interventional clinical trial testing the hypothesis that subcutaneous (s.c.) once-weekly semaglutide can improve intestinal permeability and reduce systemic inflammation in participants with type 2 diabetes (T2D) and obesity.

Methods: SIB (NCT04979130) is an investigator-initiated, single-center randomized, double-blinded, placebo-controlled clinical study being conducted at the University of Colorado Anschutz Medical Campus. The primary objective of this novel trial is to test the hypothesis that subcutaneous (s.c.) once-weekly semaglutide could improve intestinal permeability and reduce systemic inflammation in participants with T2D and obesity. Eligible participants had a diagnosis of type 2 diabetes, elevated body mass index, and evidence of systemic inflammation. Participants were randomized 1:1 to s.c. semaglutide or placebo. Participants were assessed for intestinal permeability and markers of inflammation at baseline, mid-study, and at the end of the study. Efficacy assessments were based on the analysis of the following: lactulose:mannitol ratio test, serum lipopolysaccharide-binding protein (LBP), fecal calprotectin, inflammatory biomarkers (IL-6, TNF, IL-1, IL-8, hs-CRP), and HbA1c. All participants who enrolled in the trial provided written informed consent after having received written and oral information on the trial. The risks of semaglutide use were minimized by administration according to FDA-labeled use and close monitoring for adverse events.

Discussion: SIB is the first study to examine the effects of GLP-1 receptor agonists on intestinal permeability in humans and will provide important data on their impact on systemic inflammation and intestinal permeability in the setting of T2D and obesity.

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CiteScore
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