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Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

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ClinicalTrials.gov Identifier: NCT03108547
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Marlies Wijsenbeek, Erasmus Medical Center

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

Condition or disease Intervention/treatment
Sarcoidosis 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
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis Associated Fatigue
Actual Study Start Date : June 13, 2014
Actual Primary Completion Date : January 5, 2015
Actual Study Completion Date : January 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Sarcoidosis

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. Fatigue Assessment Scale (FAS) [ Time Frame: 1 day ]
    A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids

  4. 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

  5. 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

  6. 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

  7. Perceived Stress Scale [ Time Frame: 1 day ]
    A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids

  8. 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

  9. % predicted forced vital capacity (FVC) [ Time Frame: 1 day ]
    To assess the relationship between scalp hair steroids and FVC

  10. % predicted diffusion capacity of carbon monoxide (DLCO) [ Time Frame: 1 day ]
    To assess the relationship between scalp hair steroids and DLCO

  11. 6-minute walk distance test (6MWT) [ Time Frame: 1 day ]
    To assess the relationship between scalp hair steroids and 6MWT

  12. Waist circumference [ Time Frame: 1 day ]
    To assess the relationship between scalp hair steroids and waist circumference

  13. Body Mass Index (BMI) [ Time Frame: 1 day ]
    To assess the relationship between scalp hair steroids and BMI


Biospecimen Retention:   Samples Without DNA
Scalp hair string


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108547


Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: M. S. Wijsenbeek, MD, PhD Erasmus University Medical Center, Rotterdam, the Netherlands

Responsible Party: Marlies Wijsenbeek, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03108547     History of Changes
Other Study ID Numbers: MEC-2014-206
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marlies Wijsenbeek, Erasmus Medical Center:
Sarcoidosis
Scalp hair cortisol and testosterone
Fatigue
Biomarker
Psychological distress

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Anti-Inflammatory Agents