NCT Number: NCT03108547
Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls
Time frame: 1 month
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
Secondary outcomes
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Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls
Time frame: 1 month
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
-
Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls
Time frame: 1 month
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
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Fatigue Assessment Scale (FAS)
Time frame: 1 day
A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids
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King's Sarcoidosis Questionnaire (KSQ)
Time frame: 1 day
A validated questionnaire to assess sarcoidosis-related health status, and its relation to scalp hair steroids
-
EuroQol-5D-5L (EQ-5D-5L)
Time frame: 1 day
A validated generic questionnaire to assess general health status, and its relation to scalp hair steroids
-
Short Form-36 (SF-36)
Time frame: 1 day
A validated generic questionnaire to assess health-related quality of life, and its relation to scalp hair steroids
-
Perceived Stress Scale
Time frame: 1 day
A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids
-
Hospital Anxiety and Depression Scale
Time frame: 1 day
A validated questionnaire to identify presence of depression and anxiety, and their relation to scalp hair steroids
-
% predicted forced vital capacity (FVC)
Time frame: 1 day
To assess the relationship between scalp hair steroids and FVC
-
% predicted diffusion capacity of carbon monoxide (DLCO)
Time frame: 1 day
To assess the relationship between scalp hair steroids and DLCO
-
6-minute walk distance test (6MWT)
Time frame: 1 day
To assess the relationship between scalp hair steroids and 6MWT
-
Waist circumference
Time frame: 1 day
To assess the relationship between scalp hair steroids and waist circumference
-
Body Mass Index (BMI)
Time frame: 1 day
To assess the relationship between scalp hair steroids and BMI
Sponsors and collaborators
Lead sponsor
Erasmus Medical Center
Other
Registry information
Official study title
Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 11, 2017
- Registry last updated
- Apr 11, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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