Genetic Risk Factor for Heat Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity of Iowa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously genotyped as a CF carrier or control
Comfortable speaking/reading English
Disqualifiers
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
Trial population
Individuals who have previously been genotyped as CF Carriers or Controls.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Heat Challenge
Procedure/SurgeryParticipants will be asked to arrive well-hydrated and to refrain from exercise, alcohol, caffeine, and smoking for 24 hours prior to the visit. Height, weight, blood pressure, and body fat percentage will be measured. Blood (15.5 ml) and urine will be collected. Participants will wear a heart rate monitor and sit in a heat chamber at 62-63 degrees Celsius for 45 minutes. Heart rate will be measured continuously. Body temperature and a self-report of their comfort (1-4 scale) and thermosensation (1-7 scale) will be measured before the challenge, every 15 minutes during the challenge, and after the challenge. During the challenge, a sample of sweat will be collected to measure electrolyte loss. Participants will consume 16 ounces of water at their own pace during the 45 minutes. If they become too uncomfortable to continue or their body temperature rises above 39 degrees Celsius, the challenge will be stopped. All baseline measures except body fat percentage will be measured again.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: CF Carriers1 intervention
Group B: Controls1 intervention
Trial outcomes
Primary outcomes
1
Participant Scores for Temperature Sensitivity and Regulation Survey
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.
Time frame
Baseline2
Change in Weight
Weight will be measured in kilograms pre- and post-heat challenge. We will compare change in weight between groups.
Time frame
Up to 45 minutes3
Change in Sodium Concentration
Sodium concentration will be measured pre- and post-heat challenge by blood draw and urine sample. Sodium concentration will be compared between groups.
Time frame
Up to 45 minutes4
Change in Potassium Concentration
Potassium concentration will be measured pre- and post-heat challenge by blood draw and urine sample. Potassium concentration will be compared between groups.
Time frame
Up to 45 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov