SarcoidosisNCT03108547
Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis
An observational study of Sarcoidosis, run by Erasmus Medical Center.
Trial summary
The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Determination of scalp hair steroids
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2014to 5 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcoidosis
- Being tested
- Determination of scalp hair steroids
- Keywords
- Sarcoidosis, Scalp hair cortisol and testosterone, Fatigue, Biomarker, Psychological distress
- Medical subject headings
- Sarcoidosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of scalp hair steroidsOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Determination of scalp hair steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (13)
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
Measured: 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
Measured: 1 month
Fatigue Assessment Scale (FAS)
A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids
Measured: 1 day
King's Sarcoidosis Questionnaire (KSQ)
A validated questionnaire to assess sarcoidosis-related health status, and its relation to scalp hair steroids
Measured: 1 day
EuroQol-5D-5L (EQ-5D-5L)
A validated generic questionnaire to assess general health status, and its relation to scalp hair steroids
Measured: 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
Measured: 1 day
Perceived Stress Scale
A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids
Measured: 1 day
Hospital Anxiety and Depression Scale
A validated questionnaire to identify presence of depression and anxiety, and their relation to scalp hair steroids
Measured: 1 day
% predicted forced vital capacity (FVC)
To assess the relationship between scalp hair steroids and FVC
Measured: 1 day
% predicted diffusion capacity of carbon monoxide (DLCO)
To assess the relationship between scalp hair steroids and DLCO
Measured: 1 day
6-minute walk distance test (6MWT)
To assess the relationship between scalp hair steroids and 6MWT
Measured: 1 day
Waist circumference
To assess the relationship between scalp hair steroids and waist circumference
Measured: 1 day
Body Mass Index (BMI)
To assess the relationship between scalp hair steroids and BMI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start13 Jun 2014
- Primary completion5 Jan 2015
- Study completion5 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies Wijsenbeek, Erasmus Medical Center
- Investigators
- M. S. Wijsenbeek, MD, PhD, Principal investigator, Erasmus University Medical Center, Rotterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108547
- Sponsor's protocol ID
- MEC-2014-206
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 31199799
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue
- ClinicalTrials.gov ID
- NCT03108547
- Acronym / sponsor ID
- MEC-2014-206
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, Scalp hair cortisol and testosterone, Fatigue, Biomarker, Psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2014 (actual)
- Primary completion
- 5 Jan 2015 (actual)
- Study completion
- 5 Jan 2015 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis - fatigued | – | Other: Determination of scalp hair steroidsMen 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. |
| Sarcoidosis - non-fatigued | – | Other: Determination of scalp hair steroidsMen 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. |
| Healthy controls | – | Other: Determination of scalp hair steroidsHair steroid values of a previously collected normal values study in adults will be used as healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of scalp hair steroids | Other | Healthy controls, Sarcoidosis - fatigued, Sarcoidosis - non-fatigued |
Primary outcome
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
13 secondary outcomes
Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls
Time frame: 1 month
Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls
Time frame: 1 month
Fatigue Assessment Scale (FAS)
Time frame: 1 day
King's Sarcoidosis Questionnaire (KSQ)
Time frame: 1 day
EuroQol-5D-5L (EQ-5D-5L)
Time frame: 1 day
Short Form-36 (SF-36)
Time frame: 1 day
Perceived Stress Scale
Time frame: 1 day
Hospital Anxiety and Depression Scale
Time frame: 1 day
% predicted forced vital capacity (FVC)
Time frame: 1 day
% predicted diffusion capacity of carbon monoxide (DLCO)
Time frame: 1 day
6-minute walk distance test (6MWT)
Time frame: 1 day
Waist circumference
Time frame: 1 day
Body Mass Index (BMI)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 31199799van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. S. Wijsenbeek, MD, PhD principal investigator
Erasmus University Medical Center, Rotterdam, the Netherlands
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.