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临床试验/NCT01694004
NCT01694004已完成1 期

Duodenal Lipid Sensing and Nutrient Absorption

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Nutrient Absorption

研究概览

简要总结

Preliminary studies in humans suggest that the presence of lipids in the gut can modify glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid) absorption from the GI tract through a gut-brain-gut axis.

详细描述

The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid tracers and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • BMI = 19-27 kg/m2
  • 30-55 years of age

排除标准

  • Contraindication for nasal tube placement (e.g. deviated septum, prior upper gastrointestinal bleed, or history of easy bleeding)
  • Prior gastric or intestinal surgery or pancreas resection
  • Females with a positive pregnancy test
  • Known history of intestinal diseases including (but not limited to) inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), celiac sprue, Barrett's esophagus
  • Type 1 or type 2 diabetes
  • Gastroenteritis (diarrhea and/or vomiting) or constipation within the past week

研究组 & 干预措施

Benzocaine Infusion into Duodenum

Experimental

The investigator will conduct a study in 20 lean (BMI = 19-27 kg/m2) subjects involving intravenous (IV) and intraduodenal (ID) infusions of glucose tracers or amino acid traces and measurement of tracer rate of appearance in the plasma. An ID infusion of LCFA will allow the investigators to determine if LCFA can alter nutrient absorption and glucose and amino acid metabolism. Benzocaine will be added to the ID infusion of LCFA to inhibit nerve terminals in the duodenum thereby preventing gut-brain communication. Plasma levels of glucose and amino acid tracers, glucose oxidation (13CO2 breath test), gut hormones (CCK, GIP, PYY, GLP-1, ghrelin), and bioactive lipids (N-acyl phosphatidylethanolamines, NAPEs) will be measured during all infusion periods.

干预措施: Benzocaine Infusion into Duodenum (Drug)

结局指标

主要结局

Nutrient Absorption

时间窗: 6 hours

Stable isotope tracers (glucose or amino acid) will be administered intravenously (IV) and intraduodenally (ID) and tracer rate of appearance in the plasma will be measured.

次要结局

  • Substrate Oxidation(6 hours)
  • Gut Hormone Levels(6 hours)

研究者

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

Robyn Tamboli

Research Assistant Professor

Vanderbilt University Medical Center

研究点 (1)

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