Status:
COMPLETED
Concentration/Meditation Limits Inflammation
Lead Sponsor:
Radboud University Medical Center
Conditions:
Autoimmune Diseases
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Auto-immune diseases are characterized by an inappropriate inflammatory response against tissues in the body and represent a major health care burden. Pro-inflammatory cytokines such as TNF-α, IL-6 an...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤35 yrs
- Male
- Healthy
- Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Exclusion
- Use of any medication
- Smoking
- Use of recreational drugs within 21 days prior to endotoxemia experiment day
- Use of caffeine or alcohol within 1 day prior to endotoxemia experiment day
- Previous participation in a trial where LPS was administered
- Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day
- Participation in another clinical trial within 3 months prior to endotoxemia experiment day.
- History, signs, or symptoms of cardiovascular disease
- History of frequent vaso-vagal collapse or of orthostatic hypotension
- History of atrial or ventricular arrhythmia
- Hypertension (RR systolic \>160 or RR diastolic \>90)
- Hypotension (RR systolic \<100 or RR diastolic \<50)
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
- Renal impairment: plasma creatinine \>120 µmol/L
- Liver function abnormality: alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
- History of asthma
- Obvious disease associated with immune deficiency.
- CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01835457
Start Date
February 1 2013
End Date
July 1 2013
Last Update
July 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB