Exploring a Common Genetic Risk Factor for Heat Stroke and Dehydration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Iowa
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Concentration of Sweat Chloride
Study Overview
Brief Summary
The goal of this observational study is to examine the effect of the Cystic Fibrosis (CF) Carrier state on the risk for dehydration and other CF-specific fluid-and-electrolyte disorders in male and female adults.
The primary aim of the study is to estimate the risk of electrolyte disorders attributable to the CF carrier state in a genotyped cohort.
This will be accomplished with two smaller projects- Aim 1 and Aim 2.
Aim 1 will consist of 100 CF Carriers and 100 age- and sex-matched controls. Participants in this aim will be asked to complete a Participant Info and Temperature Survey consisting of questions about race, ethnicity, medical history, and how they experience heat.
Aim 2 will consist of a subset of 25 CF Carriers and 25 age- and sex-matched controls from Aim 1. Participants in this aim will be scheduled for a visit to complete a heat challenge. At this visit, they will also complete the Participant Info and Temperature Survey. They will also sit in a sauna at 62 - 63 degrees Celsius for 45 minutes.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previously genotyped as a CF carrier or control
- •Comfortable speaking/reading English
Exclusion Criteria
- •Previously genotyped as a CF patient
- •Diagnosis of Type 1 or Type 2 diabetes
- •History of heart attack, stroke, heart failure, or atherosclerosis
- •Currently pregnant
- •Currently taking beta blockers or diuretics
- •Prisoner status
- •Unable to provide own written informed consent
Arms & Interventions
CF Carriers
Participants who have previously been genotyped as CF Carriers.
Intervention: Heat Challenge (Procedure)
Controls
Participants who have previously been genotyped as controls and are age- and sex-matched to a CF Carrier.
Intervention: Heat Challenge (Procedure)
Outcomes
Primary Outcomes
Concentration of Sweat Chloride
Time Frame: Up to 45 minutes
Sweat chloride will be measured pre- and post-heat challenge by sweat collection. Sweat chloride will be compared between groups.
Change in Sodium Concentration
Time Frame: Up to 45 minutes
Sodium concentration will be measured pre- and post-heat challenge by blood draw and urine sample. Sodium concentration will be compared between groups.
Participant Scores for Temperature Sensitivity and Regulation Survey
Time Frame: Baseline
Individual and composite scores for 5 components of the Temperature Sensitivity Survey (Heat- and Activity-Induced Autonomic Thermoregulation; Heat-Induced Behavioral Thermoregulation; Heat Perception; and Heat- and Activity-Induced Fatigue). For these 5 components, there are a total of 25 questions. All questions are on a 7-point scale, with the highest representing the most sensitive to heat and the lowest being the least sensitive. We will add up the scores for each question to arrive at a composite score for each component and the component scores will be added to arrive at a total score. Scores will be compared between groups.
Change in Weight
Time Frame: Up to 45 minutes
Weight will be measured in kilograms pre- and post-heat challenge. We will compare change in weight between groups.
Change in Potassium Concentration
Time Frame: Up to 45 minutes
Potassium concentration will be measured pre- and post-heat challenge by blood draw and urine sample. Potassium concentration will be compared between groups.
Final Score on Comfort Scale
Time Frame: Up to 45 minutes
Participants will rate their level of comfort on a scale of 1-4 at the end of the heat challenge. Scores will be compared between groups.
Final Score on Thermosensation Scale
Time Frame: Up to 45 minutes
Participants will rate their level of thermosensation on a scale of 1-7 at the end of the heat challenge. Scores will be compared between groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Aaron C. Miller
Research Assistant Professor
University of Iowa