Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-13

Study Completion Date

2015-01-05

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.

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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.

Conditions

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Sarcoidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Determination of scalp hair steroids

Intervention Type OTHER

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.

Determination of scalp hair steroids

Intervention Type OTHER

Healthy controls

Hair steroid values of a previously collected normal values study in adults will be used as healthy controls

Determination of scalp hair steroids

Intervention Type OTHER

Interventions

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Determination of scalp hair steroids

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No