Aging and Gastrointestinal Barrier Function

Last updated: January 21, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

N/A

Condition

Aging

Fever

Treatment

Hyperthermia Trial

Control Trial

Controlled hyperthermia

Clinical Study ID

NCT05816551
STU-2023-0171
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male and female individuals

  • 18-35 years or 65+ years of age

  • Free of any underlying moderate to serious medical conditions

Exclusion

Exclusion Criteria:

  • Known heart disease

  • Any chronic medical conditions requiring regular medical therapy including cancer,diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolledhypercholestrolmia etc;

  • Abnormality detected on routine screening suggestive of provocable ischemia orpreviously undetected cardiac disease or resting left bundle branch block onscreening electrocardiogram.

  • Current smokers, as well as individuals who regularly smoked within the past 3 years

  • Subject with a body mass index ≥35 kg/m2

  • Pregnant

  • 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

Study Design

Total Participants: 22
Treatment Group(s): 3
Primary Treatment: Hyperthermia Trial
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
September 30, 2024

Study Description

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.

Connect with a study center

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

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