Metabolic Syndrome Clinical Trial
— CortILOfficial title:
Effects of IL-1 Beta on the Hypothalamic-pituitary-adrenal (HPA) Axis in Obese Persons - the CortIL-Study
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 tissue production of IL-1β. Furthermore, IL-1β is also known to stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby explaining the observed hypercortisolism.
Status | Completed |
Enrollment | 76 |
Est. completion date | July 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hopsital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morning cortisol levels | 14 days | No | |
Secondary | effect of anakinra/Kineret® on salivary cortisol, free urinary cortisol, and serum cortisol levels after an overnight dexamethasone suppression test | 14 days | No | |
Secondary | correlation between the percentage of body fat or body mass index, and suppression of cortisol levels after injection of anakinra/Kineret® | 14 days | No | |
Secondary | correlation between inflammatory parameters with cortisol levels | 14 days | No | |
Secondary | impact of anakinra/Kineret® on other pituitary and peripheral hormones, such as: ACTH, TSH, fT4, GH, IGF-1, LH, FSH, testosterone copeptin, IL-6, CRP, leukocyte count and body temperature. | impact of anakinra/Kineret® on other pituitary and peripheral hormones such as: ACTH, thyroid-stimulating Hormone (TSH), free thyroxine 4 (fT4), growth Hormone (GH), insulin like growth factor (IGF)-1, luteinizing Hormone (LH), follicle stimulating Hormone (FSH), testosterone copeptin, interleukin (IL)-6, C reactive protein (CRP), leukocyte count and body temperature. | 14 days | No |
Secondary | comparison of 1mg and 2mg dexamethasone suppression test | 4 weeks | No |
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