CompletedPhase 3

Effects of IL-1 Beta on the HPA-axis in Obese Persons

Switzerland76 participantsStarted 2014-10

Plain-language 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 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Morning cortisol levels

Timeframe: 14 days

Trial details

NCT IDNCT02227420

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

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