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临床试验/NCT03464240
NCT03464240已完成不适用

Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans

University Health Network, Toronto4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2015年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
4
主要终点
Visualization of lipid stores in the gut

研究概览

简要总结

During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines how glucose ingestion releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

详细描述

Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

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

入选标准

  • Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by endoscopy doctor.
  • Body mass index 20 to 27 kg/m2

排除标准

  • Patients with active inflammatory bowel disease
  • Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
  • Patients with active bowel malignancy
  • Patients with diabetes mellitus or known/ suspected motility disorders of the gut
  • Patients with decompensated liver disease
  • Patients on ezetimibe or bile acid sequestrants
  • Unstable cardiac or respiratory disease
  • Any changes to medication in the preceding month

结局指标

主要结局

Visualization of lipid stores in the gut

时间窗: 6-10 hours

Electron microscopy observation gut samples in response to glucose versus water drink

次要结局

  • Analysis of proteins in the gut(6-10 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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