Aging and Gastrointestinal Barrier Function

Aging Clinical Trial

Official title:

Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05816551
• Other study ID #: STU-2023-0171
• Status: Active, not recruiting
• Start date: July 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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. Comprehensive assessments of gastrointestinal barrier function, microbial translocation and systemic inflammation will be assessed in young and older adults. The expected outcome of this work will re-shape out understanding of the consequences of aging on gastrointestinal barrier function during heat waves.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Criteria:

• 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

• Pregnant

• Chronic fatigue syndrome

• Use of immunosuppressant drugs within last 4 weeks prior to screening

• Diagnosed psychiatric disease

• 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

Related Conditions & MeSH terms

• Aging
• Fever
• Hyperthermia

Intervention

Other:
• Controlled hyperthermia
Individuals will be exposed to a control trial (no hyperthermia) and a controlled hyperthermia trial.

Locations

Country	Name	City	State
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal permeability before hyperthermia	In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine.	Day 1: 3-5 hours after ingestion of multiple sugar drink.
Primary	Gastrointestinal permeability after hyperthermia	In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine.	Day 2: 3-5 hours after ingestion of multiple sugar drink.
Secondary	Microbiota diversity at baseline	Fecal samples will be used for next-generation sequencing and analyzed for diversity.	Day 1: Control trial
Secondary	Bacterial species - at baseline	Fecal samples will be used for next-generation sequencing and analyzed for bacterial species.	Day 1: Control trial
Secondary	Microbial translocation	Venous blood samples will be used for next-generation sequencing and analyzed for bacterial species.	Day 2: Directly before and immediately after the controlled hyperthermia
Secondary	Systemic inflammation	Venous blood samples will be assessed for systemic pro-inflammatory markers a) tumor necrosis factor alpha, interleukin 6, and soluble cd14 receptor.	Day 2: Directly before and immediately after the controlled hyperthermia
Secondary	Gastrointestinal blood flow	Gastrointestinal blood flow will be measured by analysing the flow of blood in the superior mesenteric artery using ultrasound	Day 2: Directly before and immediately after the controlled hyperthermia
Secondary	Skin blood flow	Skin blood flow will be measured using laser doppler flowmetry	Day 2: Before and continuously during controlled hyperthermia