Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

Study Overview
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Brief Summary
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The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.

Detailed Description
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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.

Official Title
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Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue

Conditions
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Sarcoidosis

Intervention / Treatment
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* Other: Determination of scalp hair steroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcoidosis - fatigued<br>Men and women with sarcoidosis and a score of ≥ 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life. | Other: Determination of scalp hair steroids<br> <br> |
| Sarcoidosis - non-fatigued<br>Men and women with sarcoidosis and a score of < 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life. | Other: Determination of scalp hair steroids<br> <br> |
| Healthy controls<br>Hair steroid values of a previously collected normal values study in adults will be used as healthy controls | Other: Determination of scalp hair steroids<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls | Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls | Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls | 1 month | 
| Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls | Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls | 1 month | 
| Fatigue Assessment Scale (FAS) | A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids | 1 day | 
| King's Sarcoidosis Questionnaire (KSQ) | A validated questionnaire to assess sarcoidosis-related health status, and its relation to scalp hair steroids | 1 day | 
| EuroQol-5D-5L (EQ-5D-5L) | A validated generic questionnaire to assess general health status, and its relation to scalp hair steroids | 1 day | 
| Short Form-36 (SF-36) | A validated generic questionnaire to assess health-related quality of life, and its relation to scalp hair steroids | 1 day | 
| Perceived Stress Scale | A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids | 1 day | 
| Hospital Anxiety and Depression Scale | A validated questionnaire to identify presence of depression and anxiety, and their relation to scalp hair steroids | 1 day | 
| % predicted forced vital capacity (FVC) | To assess the relationship between scalp hair steroids and FVC | 1 day | 
| % predicted diffusion capacity of carbon monoxide (DLCO) | To assess the relationship between scalp hair steroids and DLCO | 1 day | 
| 6-minute walk distance test (6MWT) | To assess the relationship between scalp hair steroids and 6MWT | 1 day | 
| Waist circumference | To assess the relationship between scalp hair steroids and waist circumference | 1 day | 
| Body Mass Index (BMI) | To assess the relationship between scalp hair steroids and BMI | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoidosis, Scalp hair cortisol and testosterone, Fatigue, Biomarker, Psychological distress