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The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Younger participants | Experimental | Individuals aged 18-39 years. |
|
| Older participants | Experimental | Individuals aged over 65 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermia Trial | Other | Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log Lactulose/Rhamnose Following Control Trial | 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. | "Visit 1": 3-5 hours after ingestion of multiple sugar drink. |
| Log Lactulose/Rhamnose Following Hyperthermia Trial | 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. | "Visit 2": 3-5 hours after ingestion of multiple sugar drink. |
| Log Sucrose Following Control Trial | 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. | "Visit 1": 3-5 hours after ingestion of multiple sugar drink. |
| Log Sucrose Following Hyperthermia Trial | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Core Temperature During Hyperthermia Trial | Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period. | "Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig G Crandall, Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Health Presbyterian Hospital Dallas | Dallas | Texas | 75231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Younger Participants | Individuals aged 18-39 years Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol. Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol. |
| FG001 | Older Participants | Individuals aged over 65 years Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol. Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Younger Participants | Individuals aged 18-39 years Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial. Control Trial: Individuals will be exposed to a control trial (no hyperthermia). |
| BG001 | Older Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Log Lactulose/Rhamnose Following Control Trial | 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. | Posted | Mean | Standard Deviation | Ratio | "Visit 1": 3-5 hours after ingestion of multiple sugar drink. |
|
During the two trials of the experiment or approximately 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Younger Participants Hyperthermia Trial | Individuals aged 18-39 years Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Crandall, PhD, Primary Investigator | Institute for Exercise and Environmental Medicine | 214-345-4623 | craigcrandall@texashealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2024 | Oct 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2024 | Oct 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| Control Trial | Other | Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol. |
|
| "Visit 2": 3-5 hours after ingestion of multiple sugar drink. |
Individuals aged over 65 years Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial. Control Trial: Individuals will be exposed to a control trial (no hyperthermia). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Older Participants |
Individuals aged over 65 years Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial. Control Trial: Individuals will be exposed to a control trial (no hyperthermia). |
|
|
| Primary | Log Lactulose/Rhamnose Following Hyperthermia Trial | 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. | Posted | Mean | Standard Deviation | Ratio | "Visit 2": 3-5 hours after ingestion of multiple sugar drink. |
|
|
|
| Primary | Log Sucrose Following Control Trial | 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. | Posted | Mean | Standard Deviation | log(ng/mL) | "Visit 1": 3-5 hours after ingestion of multiple sugar drink. |
|
|
|
| Primary | Log Sucrose Following Hyperthermia Trial | 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. | Posted | Mean | Standard Deviation | log(ng/mL) | "Visit 2": 3-5 hours after ingestion of multiple sugar drink. |
|
|
|
| Secondary | Change in Core Temperature During Hyperthermia Trial | Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period. | Posted | Mean | Standard Deviation | °C | "Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Older Participants Hyperthermia Trial | Individuals aged over 65 years Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG002 | Younger Participants Control Trial | Individuals aged 18-39 years Control Trial: Individuals will be exposed to a control trial (no hyperthermia). | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Older Participants Control Trial | Individuals aged over 65 years Control Trial: Individuals will be exposed to a control trial (no hyperthermia). | 0 | 9 | 0 | 9 | 0 | 9 |
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| D014947 | Wounds and Injuries |