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临床试验/NCT05816551
NCT05816551已完成不适用

Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年7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
已完成
入组人数
22
试验地点
1
主要终点
Log Lactulose/Rhamnose Following Control Trial

研究概览

简要总结

The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.

详细描述

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Although gastrointestinal barrier dysfunction is a primary cause of heat related illness, little is known about the effects of aging on gastrointestinal barrier function during hyperthermia. The central hypothesis of this work is that the elderly exhibit greater gastrointestinal barrier dysfunction during hyperthermia. Participants will complete a control trial where gastrointestinal permeability (without heating) will be assessed in young and older adults. In the experimental trial, controlled hyperthermia will be achieved using a water perfused, tube lined suit. Core body temperature will be raised to a maximum of 2 degrees Celsius above the baseline value, or an absolute temperature of 39.5 degrees Celsius. Core temperature will not be collected during the control trial. Comprehensive assessments of gastrointestinal barrier function and systemic inflammation will be assessed in young and older adults. The expected outcome of this work will re-shape our understanding of the consequences of aging on gastrointestinal barrier function during heat waves.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy male and female individuals
  • •18-35 years or 65+ years of age
  • •Free of any underlying moderate to serious medical conditions

排除标准

  • •Known heart disease
  • •Any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc;
  • •Abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
  • •Current smokers, as well as individuals who regularly smoked within the past 3 years
  • •Subject with a body mass index ≥35 kg/m2
  • •Use of immunosuppressant drugs within last 4 weeks prior to screening
  • •Use of antibiotics or antimicrobial medication in last month
  • •Any previous abdominal surgery
  • •Use of steroids in last 6 weeks
  • •Regular use of probiotics in last month
  • •Use of laxatives or anti-diarrhetic in last month

研究组 & 干预措施

Older participants

Experimental

Individuals aged over 65 years.

干预措施: Hyperthermia Trial (Other)

Older participants

Experimental

Individuals aged over 65 years.

干预措施: Control Trial (Other)

Younger participants

Experimental

Individuals aged 18-39 years.

干预措施: Hyperthermia Trial (Other)

Younger participants

Experimental

Individuals aged 18-39 years.

干预措施: Control Trial (Other)

结局指标

主要结局

Log Lactulose/Rhamnose Following Control Trial

时间窗: "Visit 1": 3-5 hours after ingestion of multiple sugar drink.

In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.

Log Lactulose/Rhamnose Following Hyperthermia Trial

时间窗: "Visit 2": 3-5 hours after ingestion of multiple sugar drink.

In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.

Log Sucrose Following Control Trial

时间窗: "Visit 1": 3-5 hours after ingestion of multiple sugar drink.

The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.

Log Sucrose Following Hyperthermia Trial

时间窗: "Visit 2": 3-5 hours after ingestion of multiple sugar drink.

The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.

次要结局

  • Change in Core Temperature During Hyperthermia Trial("Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.)

研究者

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

Craig Crandall

Professor

University of Texas Southwestern Medical Center

研究点 (1)

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