Exploring the incidence of fatigue after sarcoidosis, its severity and nature. Next we will try to associate fatigue with capacity to produce pro- and anti-inflammatory cytokines.Our secondary objective is testing the activity of the HPA-axis, the…
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Immune disorders NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
HPA-axis (cortisol, ACTH), autonomous responses (catecholaminen, bloodpressure,
heartfrequency), psychologic characteristics (cynical hostility), pain
complaints, function of neuroanatomical pain pathways (LEP) and sensitisation
(GRK).
Background summary
Fatigue appears to be the most commonly reported complaint by part of the
patients suffering from sarcoidosis. Not only during the active phase of this
multi-systemic granulomatous disorder, but also when, clinically, no
disease-activity can be found anymore, fatigue may persist. Also for pain, this
seems the case. So far research has not offered reliable rates on incidence nor
a plausible explanation for this fatigue nor for these pain complaints. Due to
this lack there is no evidence based treatment to offer these patients.
Study objective
Exploring the incidence of fatigue after sarcoidosis, its severity and nature.
Next we will try to associate fatigue with capacity to produce pro- and
anti-inflammatory cytokines.
Our secondary objective is testing the activity of the HPA-axis, the autonomic
response and psychological characteristics in order to find a correlation with
fatigue.
In addition we will investigate pain complaints and test the functionality of
the neuroanamtomic pain pathways. Lastly we will determinate the activity of
GRK to assess possible sensitisation.
Study design
an observational, follow up study of a cohort of post-sarcoidosis patients.
This cohort consists of patients who had their first broncho alveolaire lavage
in the period 1998 - 2003
All patients will fill out the fatigue questionnaire (CIS-20) to estimate the
incidence of fatigue. Next we will explore associations of fatigue with
production of pro- and anti-inflammatory cytokines, psychological
characteristics, the activity of the HPA-axis and the autonomous response.
Study burden and risks
Screening: physical examination, x-thorax, lungfunction test, urine- and
bloodsampling
Study: 6 questionnaires; 1 anamnesis; muscle force tests; actometer (12 days);
1 Trier Social Stress Test (including an extra bloodsample), 1 physical
examination (neurologist), 1 Laser Evoked Potentials test, 24h sleep diary (7
days).
Risk for all participants is minimal. Risk intravenous catheter is an
haematoma. Risk of LEP is an irritated skin that resolves within days.
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14786.100.06 |