Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarcoidosis - fatigued | 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. |
| |
| Sarcoidosis - non-fatigued | 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. |
| |
| Healthy controls | Hair steroid values of a previously collected normal values study in adults will be used as healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Determination of scalp hair steroids | Other |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| M. S. Wijsenbeek, MD, PhD | Erasmus University Medical Center, Rotterdam, the Netherlands | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31199799 | Derived | van Manen MJG, Wester VL, van Rossum EFC, van den Toorn LM, Dorst KY, de Rijke YB, Wijsenbeek MS. Scalp hair cortisol and testosterone levels in patients with sarcoidosis. PLoS One. 2019 Jun 14;14(6):e0215763. doi: 10.1371/journal.pone.0215763. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
Not provided
Not provided
Not provided
Not provided
Not provided
Scalp hair string
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 |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |