Observational Study on CF Carrier State and Heat Stroke Risk
This observational study is looking at how being a carrier of the Cystic Fibrosis (CF) gene might affect your risk for dehydration and other fluid-and-electrolyte problems, which can lead to heat stroke. Researchers want to understand if carrying the CF gene increases the chance of these issues. You could join if you are between 18 and 60 years old, have been previously identified as a CF carrier or a control (someone without the CF gene), and can speak and read English comfortably. You cannot join if you have diabetes, a history of heart problems, are pregnant, or are taking certain medications. The study will measure changes in your weight and sodium levels after a "Heat Challenge" procedure to see if there's a link. The study is currently unclear on its recruitment status and plans to enroll 200 participants.
- Study design
- This is an observational study involving 200 participants, divided into 100 CF carriers and 100 age- and sex-matched controls. It is not a randomized or blinded study.
- What's involved
- You will be asked to complete a survey about your medical history and how you experience heat. You will also undergo a "Heat Challenge" procedure involving blood and urine collection, lasting up to 45 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your weight and sodium concentration will be measured up to 45 minutes after the Heat Challenge procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Genetic Risk Factor for Heat Stroke
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Aaron Miller, PhD · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Participant Scores for Temperature Sensitivity and Regulation SurveyBaseline
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 WeightUp to 45 minutes
Weight will be measured in kilograms pre- and post-heat challenge. We will compare change in weight between groups.
- Change in Sodium ConcentrationUp 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.
- Change in Potassium ConcentrationUp 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.
- Concentration of Sweat ChlorideUp to 45 minutes
Sweat chloride will be measured pre- and post-heat challenge by sweat collection. Sweat chloride will be compared between groups.
- Final Score on Comfort ScaleUp 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 ScaleUp 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.