Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02227420
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02227420
Study Brief:
Protocol Section:
NCT02227420