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

Metabolic Syndrome Clinical Trial

— CortIL  

Official title:

Effects of IL-1 Beta on the Hypothalamic-pituitary-adrenal (HPA) Axis in Obese Persons - the CortIL-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227420
• Other study ID #: EKNZ 2014-175
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2014
• Last updated: August 22, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypersecretion; Cortisol
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Anakinra
Anakinra 100mg s.c. x 5

Locations

Country	Name	City	State
Switzerland	University Hopsital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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