'Post-sarcoidosis' fatigue: a psychoneuroimmunologic approach

Completed

Conditions: Morbus Besnier Boeck Schaumann
Sarcoidosis
10001353
10027665
10038716

Registration Number: NL-OMON30778

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

· Evidence on the presence of active sarcoidosis is absent, over the last 6 months:
- normal serum parameters (ACE, serum IL-2, calcium)
- röntgenogram/CTscan: normal or >= 2 yr. stable
- lungfuction: normal or >= 2 yr. stable (< 10% change of VC or FEV1, < 15%change of DLco)
· No clinical evidence of disease activity of previously involved organs
· Sarcoidosis is diagnosed based according to the latest ATS/ERS/WASOG statement on sarcoidosis, i.e.: histologic demonstration of noncaseating granulomas in combination with compatible clinical findings and exclusion of other causes of granuloma formation
· Capability of giving informed consent

Exclusion Criteria

· Sarcoidosis presented as Löfgren*s syndrome
· Medication with corticosteroids or other immunosuppressive drugs over the last 6 months
· Antidepressiva
· Psychiatric diseases (major depression, schizophrenia, dementia, anorexia nervosa. bulimia nervosa)
· Sleep apnoea or narcolepsy or restess legs syndrome
· Any diagnosed disease or any significant abnormal and clinically relevant laboratory test that could possibly contribute to fatigue
(Hb, BSE, leukocytes and differentiation, Na, K, Ca, creatine, bicarbonate, AF, ALAT, creatine phosphokinase (CPK), glucose, total protein, protein spectrum, thyroid stimulating hormone (TSH), ferritine en urine)
· Body Mass Index (BMI): >= 45 or BMI<17
· Abuse of alcohol, drugs or other substance

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fatigue: measured with the CIS20-questionnaire. The cut-off point for severe<br /><br>fatigue is set at a score of 40 or more on the subscale Severity of Fatigue<br /><br>(subscale scores ranges from 8 to 56).<br /><br>Measurements in serum: First Th1 / Th2 ratio will be determined. Secondly the<br /><br>ratio will be measured for the following cytokines: interferon (IFN)-g / IL-4.<br /><br>Lastly, IL-1 and IL6 will be analysed in the supernatants. Method to be used:<br /><br>LUMINEX.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>HPA-axis (cortisol, ACTH), autonomous responses (catecholaminen, bloodpressure,<br /><br>heartfrequency), psychologic characteristics (cynical hostility), pain<br /><br>complaints, function of neuroanatomical pain pathways (LEP) and sensitisation<br /><br>(GRK).</p><br>