Clinical trial NCT03108547: Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis
Official title: Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Keywords: Sarcoidosis
Scalp hair cortisol and testosterone
Fatigue
Biomarker
Psychological distress
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls
timeFrame: 1 month
Secondary outcomes:
measure: Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls
timeFrame: 1 month
measure: Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls
timeFrame: 1 month
measure: Fatigue Assessment Scale (FAS)
timeFrame: 1 day
measure: King's Sarcoidosis Questionnaire (KSQ)
timeFrame: 1 day
measure: EuroQol-5D-5L (EQ-5D-5L)
timeFrame: 1 day
measure: Short Form-36 (SF-36)
timeFrame: 1 day
measure: Perceived Stress Scale
timeFrame: 1 day
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 day
measure: % predicted forced vital capacity (FVC)
timeFrame: 1 day
measure: % predicted diffusion capacity of carbon monoxide (DLCO)
timeFrame: 1 day
measure: 6-minute walk distance test (6MWT)
timeFrame: 1 day
measure: Waist circumference
timeFrame: 1 day
measure: Body Mass Index (BMI)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus University Medical Center, Rotterdam, the Netherlands
name: M. S. Wijsenbeek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.