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临床试验/NCT02292121
NCT02292121终止不适用

Intestinal Permeability in Obesity of Intercellular Tight Junctions to Metabolic Complications

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
80
试验地点
2
主要终点
urinary lactitol / mannitol ratio by an intestinal permeability test (IPT)

研究概览

简要总结

In rodents, obesity is associated with changes in tight junctions' structure in small intestine, which impacts intestinal permeability and results in metabolic complications. Few data exist in human. We hypothesized that intestinal permeability is altered in obese subjects in comparison to lean subjects, linked to metabolic and inflammatory status and that these alterations are modified after gastric bypass.

详细描述

The regulation of the permeability of the intestinal barrier is essential in the molecular traffic between the lumen and the internal environment. It affects the absorption of nutrients and tolerance or immunization against foodborne non-self antigens that penetrate the barrier. In rodents, increased endotoxemia has been proposed as an important player in low-grade inflammation accompanying the development of obesity and metabolic disorders. In humans, the intestinal barrier function is altered in inflammatory bowel diseases (IBD, Crohn's disease, ulcerative colitis and celiac disease). The term "leaky gut" is used to describe a porous intestine with hyper-permeability associated with acute or chronic inflammatory diseases such as "systemic inflammatory response syndrome (SIRS),"acute inflammatory bowel disease (IBD for "inflammatory bowel disease").

Deficiencies of the barrier are also observed in extra-intestinal diseases (type-1 diabetes, food allergies, and autoimmune diseases). Impairments in tight junctions may precede clinical signs and constitute a risk factor for developing diseases or secondarily be altered and cause an increased entry of undesirable bacterial or nutritional antigens. The state of the intercellular tight junctions of the intestine controls the diffusion of molecules between cells. A deficiency of the intestinal barrier function is often associated with structural changes in the tight junctions resulting from loss of localization of protein or expression of genes and / or cellular signals such as ZO-1, occludin or tricellulin.

There are few studies about the condition of the intestinal barrier in the context of human obesity.

The objectives of our study are to :

  • compare intestinal permeability in obese subjects with non obese subjects and after gastric bypass.
  • search links between intestinal permeability and 1) metabolic and inflammatory bioclinical parameters 2) dietary profiles 3) microbiota

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

urinary lactitol / mannitol ratio by an intestinal permeability test (IPT)

时间窗: before gastric bypass and 6 months after

Measures of urinary lactitol / mannitol ratio by an intestinal permeability test (IPT) in obese patients before gastric bypass and 6 months after

次要结局

  • surgical samples during surgery (sub-cutaneous and visceral adipose tissue)(intraoperative)
  • fasting zonulin serum concentrations(before gastric bypass and 6 months after)
  • urinary lactitol / mannitol ratio by an intestinal permeability test (IPT)(inclusion and after one month)
  • LPS serum concentrations(before gastric bypass and 6 months after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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