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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Interleukin 1 Receptor Antagonist Protein

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