Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-11-19
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CF Carriers
Participants who have previously been genotyped as CF Carriers.
Heat Challenge
Participants 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.
Controls
Participants who have previously been genotyped as controls and are age- and sex-matched to a CF Carrier.
Heat Challenge
Participants 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.
Interventions
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Heat Challenge
Participants 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.
Eligibility Criteria
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Inclusion Criteria
* Comfortable speaking/reading English
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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Aaron C. Miller
Research Assistant Professor
Principal Investigators
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Aaron Miller, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Health Care
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202308319
Identifier Type: -
Identifier Source: org_study_id
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