Status:
COMPLETED
Effects of IL-1 Beta on the HPA-axis in Obese Persons
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Metabolic Syndrome
Hypersecretion; Cortisol
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
In obese individuals cortisol production and secretion is increased but the underlying mechanism is not known. Obesity leads to a pathological activation of the innate immune system partly driven by t...
Eligibility Criteria
Inclusion
- Age 18-80 years
- BMI \>30kg/m2 and at least 1 manifestations of the metabolic syndrome (i.e. diabetes/ prediabetes, hypertension, dyslipidemia)
- Willingness to use contraceptive measures adequate to prevent becoming pregnant
Exclusion
- Medication with glucocorticosteroids
- Known Cushing Syndrome
- Pregnancy or breast feeding
- Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months
- Hematologic disease (leukocyte count \< 1.5x109/l, hemoglobin \<11 g/dl, platelets \<100 x 103/ul)
- Kidney disease (creatinine-clearance \< 30ml/min))
- Liver disease (transaminases \>4x upper normal range)
- Active carcinoma
- History of tuberculosis
- Alcohol consumption \>40g/d for men, \>30g/d for women
- Known allergy towards anakinra
- Subject refusing or unable to give written informed consent
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02227420
Start Date
October 1 2014
End Date
July 1 2016
Last Update
August 23 2016
Active Locations (1)
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1
University Hopsital Basel
Basel, Switzerland