Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls
研究概览
简要总结
The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.
详细描述
Rationale: Fatigue is a common symptom in patients with sarcoidosis and has great impact on quality of life. Several aspects in the pathogenesis of sarcoidosis and co-morbidities accompanying sarcoidosis could contribute to fatigue. However, until now the etiology of fatigue in sarcoidosis is unknown. Measurements of steroid hormones in scalp hair could possibly be directional in elucidating the underlying mechanism and could also be used as a screening and follow up tool in interventional studies.
Objective
A pilot to investigate whether cortisol and testosterone levels measured in hair differ between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue and healthy subjects.
Study design: A prospective observational study, using hair samples of sarcoidosis patients with and without fatigue, compared to an already existing age matched healthy control group.
Study population: Adult sarcoidosis patients at the outpatient clinic of the pulmonary department of the Erasmus MC, Rotterdam Main study parameters/endpoints: Cortisol and testosterone levels in scalp hair, correlation with Fatigue Assessment Scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age of at least 18 years
- •Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
- •Able to speak, read and write in Dutch
- •Presence of sarcoidosis related fatigue, defined as a ≥ 22 score on the Fatigue Assessment Scale
- •Other causes of fatigue are excluded or contributing comorbidities are optimally treated (e.g. OSAS, hypothyroidism or anemia)
排除标准
- •Unable to understand questionnaires (intellectual impaired or language barrier)
- •Hair length < 1 cm
- •Use of systemic and/ or inhalation steroids in the last year
- •Use of methylphenidate (Ritalin) < 1 month before the study
结局指标
主要结局
Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls
时间窗: 1 month
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
次要结局
- Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls(1 month)
- King's Sarcoidosis Questionnaire (KSQ)(1 day)
- % predicted diffusion capacity of carbon monoxide (DLCO)(1 day)
- Body Mass Index (BMI)(1 day)
- Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls(1 month)
- Fatigue Assessment Scale (FAS)(1 day)
- EuroQol-5D-5L (EQ-5D-5L)(1 day)
- Short Form-36 (SF-36)(1 day)
- % predicted forced vital capacity (FVC)(1 day)
- Perceived Stress Scale(1 day)
- Hospital Anxiety and Depression Scale(1 day)
- 6-minute walk distance test (6MWT)(1 day)
- Waist circumference(1 day)
研究者
Marlies Wijsenbeek
Principal Investigator
Erasmus Medical Center