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'Post-sarcoidosis' fatigue: a psychoneuroimmunologic approach

'Post-sarcoidosis' fatigue: a psychoneuroimmunologic approach - 'Post-sarcoidosis' fatigue

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30778
Enrollment
75
Registered
2006-12-06
Start date
2007-07-04
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbus Besnier Boeck Schaumann Sarcoidosis

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
HPA-axis (cortisol, ACTH), autonomous responses (catecholaminen, bloodpressure, heartfrequency), psychologic characteristics (cynical hostility), pain complaints, function of neuroanatomical pain pathways (LEP) and sensitisation (GRK).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)