Genetic Risk Factor for Heat Stroke

University of Iowa

Status: Enrolling

Conditions: Heat Stroke; Dehydration; Carrier State

Treatments: Procedure: Heat Challenge

Study type: Observational

Funder types: Other

Identifiers

NCT06847256

202308319

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

CF Carriers

Description:

Participants who have previously been genotyped as CF Carriers.

Treatment:

Procedure: Heat Challenge

Controls

Description:

Participants who have previously been genotyped as controls and are age- and sex-matched to a CF Carrier.

Treatment:

Procedure: Heat Challenge