Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue

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

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Other: Determination of scalp hair steroids

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.

• Study Type: Observational
• Enrollment (Actual): 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Determination of scalp hair steroids
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.	Other: Determination of scalp hair steroids
Healthy controls; Hair steroid values of a previously collected normal values study in adults will be used as healthy controls	Other: Determination of scalp hair steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: M. S. Wijsenbeek, MD, PhD, Erasmus University Medical Center, Rotterdam, the Netherlands

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2014
• Primary Completion (Actual): January 5, 2015
• Study Completion (Actual): January 5, 2015

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Biomarker; Fatigue; Psychological distress; Sarcoidosis; Scalp hair cortisol and testosterone
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: MEC-2014-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No