A Study to Assess the Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy Compared Healthy Controls.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Sweat sodium concentration (mmol∙L-1)
研究概览
简要总结
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population resulting in poor function and/or production of the CF transmembrane conductance regulator (CFTR) protein. The CFTR protein plays a crucial role in the secretion and re-absorption of sodium chloride within the sweat gland. The sweat gland has played a key role in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Kaftrio®, a newly approved pharmacological therapy has shown a rapid and sustained reduction in sweat chloride levels on initiation of this treatment. This study will aim to play a crucial part in understanding the sweat response, sweat composition and the thermoregulatory response to exercise in the heat in people with CF on Kaftrio®.
详细描述
Cystic fibrosis (CF) is a common inherited condition in the Caucasian population, affecting approximately 52, 246 people in Europe. Mutations in the CF transmembrane conductance regulator (CFTR) gene results in poor function or production of the CFTR protein which functions as an anion channel to transport ions across the cell membrane.
The sweat gland has played a substantial part in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. Traditionally, abnormal function of the CFTR protein in the sweat gland results in failure to reabsorb sodium chloride leading to excessive salt loss. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating.
Over the last decade pharmacological therapies (CFTR modulator therapies (CFTRm)) which target the underlying cellular defect characterising CFTR in people with CF have been developed. Kaftrio® is now the most widely used modulator therapy. Studies have shown a rapid and sustained reduction in sweat chloride levels on initiation of these highly effective CFTRm. The need for salt supplementation may be influenced when taking CFTRm. Therefore, there is a need to further understand the sweat response relative to the needs in people with CF.
This study will recruit 9 people with CF who currently taking Kaftrio® and 9 healthy age-, sex- and weight-matched controls who are ≥ 18 years old. We will ask all participants to attend the laboratories for 2 visits. Visit 1 is designed to calculate metabolic heat production during different cycling intensities in order to set the workload for visit 2 relative to their metabolic heat production. Visit 2 is designed to collect sweat and thermoregulatory indices during 1 hour of cycling in the heat.
This study will compare the sweating and thermoregulatory response to exercising in the heat in a group of people with CF who are stable on Kaftrio® compared to a healthy matched control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sweat sodium concentration (mmol∙L-1)
时间窗: Day 2 - baseline
Between group differences in sweat sodium concentration
次要结局
- Cutaneous blood flux(Day 2 - baseline)
- Perception of thermal comfort(Day 2 - baseline)
- Heat sensitivity(Day 2 - baseline)
- Whole-body sweat rate (mL)(Day 2 - baseline)
- Forearm sweat rate (mg∙min-1∙cm2)(Day 2 - baseline)
- Mid-back sweat rate (mg∙min-1∙cm2)(Day 2 - baseline)
- Sweat gland activity (gland∙cm2)(Day 2 - baseline)
- Mean skin temperature (°C)(Day 2 - baseline)
- Core temperature (°C)(Day 2 - baseline)
- Change in thermal comfort(Day 2 - baseline)
- Maximal oxygen uptake (VO2 max)(Day 1 - baseline)
- Heart rate (b∙min-1)(Day 2 - baseline)
- Urine osmolality (mOsmol/kg)(Day 2 - baseline)
- Perception of temperature sensation(Day 2 - baseline)
- Rate of change in thermal comfort(Day 2 - baseline)
- Heat illness symptom index(Day 2 - baseline)
研究者
Dr Zoe Saynor
Reader (Associate Professor) in Clinical Exercise Physiology
University of Portsmouth