Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108547
• Other study ID #: MEC-2014-206
• Status: Completed
• Phase: N/A
• First received: March 31, 2017
• Last updated: April 5, 2017
• Start date: June 13, 2014
• Est. completion date: January 5, 2015

Study information

• Verified date: April 2017
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 5, 2015
• Est. primary completion date: January 5, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• Determination of scalp hair steroids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Fatigue Assessment Scale (FAS)	A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids	1 day
Secondary	King's Sarcoidosis Questionnaire (KSQ)	A validated questionnaire to assess sarcoidosis-related health status, and its relation to scalp hair steroids	1 day
Secondary	EuroQol-5D-5L (EQ-5D-5L)	A validated generic questionnaire to assess general health status, and its relation to scalp hair steroids	1 day
Secondary	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
Secondary	Perceived Stress Scale	A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids	1 day
Secondary	Hospital Anxiety and Depression Scale	A validated questionnaire to identify presence of depression and anxiety, and their relation to scalp hair steroids	1 day
Secondary	% predicted forced vital capacity (FVC)	To assess the relationship between scalp hair steroids and FVC	1 day
Secondary	% predicted diffusion capacity of carbon monoxide (DLCO)	To assess the relationship between scalp hair steroids and DLCO	1 day
Secondary	6-minute walk distance test (6MWT)	To assess the relationship between scalp hair steroids and 6MWT	1 day
Secondary	Waist circumference	To assess the relationship between scalp hair steroids and waist circumference	1 day
Secondary	Body Mass Index (BMI)	To assess the relationship between scalp hair steroids and BMI	1 day