Exploring a Common Genetic Risk Factor for Heat Stroke and Dehydration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Participant Scores for Temperature Sensitivity and Regulation Survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously genotyped as a CF carrier or control
- •Comfortable speaking/reading English
排除标准
- •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
研究组 & 干预措施
CF Carriers
Participants who have previously been genotyped as CF Carriers.
干预措施: Heat Challenge (Procedure)
Controls
Participants who have previously been genotyped as controls and are age- and sex-matched to a CF Carrier.
干预措施: Heat Challenge (Procedure)
结局指标
主要结局
Participant Scores for Temperature Sensitivity and Regulation Survey
时间窗: 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
时间窗: 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 Sodium Concentration
时间窗: 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.
Change in Potassium Concentration
时间窗: 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.
Concentration of Sweat Chloride
时间窗: Up 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 Scale
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Aaron C. Miller
Research Assistant Professor
University of Iowa