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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02227420
Other study ID # EKNZ 2014-175
Secondary ID
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


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
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