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临床试验/NCT04579900
NCT04579900招募中不适用

Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

Laval University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Microbial signature

研究概览

简要总结

It is now well documented that changes in gut microbiota composition accompany obesity and type 2 diabetes (T2D) and contribute to low-grade inflammation, insulin resistance,and glucose intolerance. It is not yet clear if T2D predisposes the intestine to allow more microbial products or possibly live bacteria to subvert the gut mucosal barrier. However, it is known that hyperglycemia during T2D induces a more permissive gut barrier allowing increased penetration of microbes and their products into the blood. An important next step is to determine which strains of bacteria promote dysbiosis, allowing bacteria or bacterial components to subvert the gut barrier and alter glucose control. It is hypothesized that gut microbes in the colon and other lower gut segments are key modulators of energy balance, glucose homeostasis and insulin sensitivity.

详细描述

The gut acts as a barrier to bacteria and nutrients and participates in glucose homeostasis via endocrine actors and the gut-brain-peripheral axis. It is unclear how T2D alters microbes in upper and lower intestine of humans. Studies in animals show that T2D promotes translocation of microbes to the blood and tissues to promote metabolic dysfunction. It is crucial to determine whether bacteria or their components subvert the gut barrier in human T2D, and then to identity the relevant bacterial strains in tissues that control blood glucose. The overall objective of our research program is to demonstrate that specific microbes in the gut, circulation, and key metabolic tissues are involved in the progression of T2D. We will define the microbial signatures of T2D in duodenal biopsies and stool samples by comparing T2D and non-T2D subjects.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •T2DB de novo or non T2DB patients

排除标准

  • •oral hypoglycemic agents or lipidlowering or antihypertensive drugs

研究组 & 干预措施

Type 2 Diabetes patients

Experimental

Upper gut biopsies and lower gut samples

干预措施: Endoscopy and duodenal biopsy and sampling (Procedure)

Non Type 2 Diabetes patients

Active Comparator

Upper gut biopsies and lower gut samples

干预措施: Endoscopy and duodenal biopsy and sampling (Procedure)

结局指标

主要结局

Microbial signature

时间窗: One week

Compare the bacterial profile of T2D and non-T2D subjects

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

André Marette

Professor

Laval University

研究点 (1)

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