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

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ClinicalTrials.gov Identifier: NCT02227420
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypersecretion; Cortisol Drug: Anakinra Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of IL-1 Beta on the Hypothalamic-pituitary-adrenal (HPA) Axis in Obese Persons - the CortIL-Study
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: Anakinra
Anakinra 100mg s.c. x 5
Drug: Anakinra
Anakinra 100mg s.c. x 5




Primary Outcome Measures :
  1. Morning cortisol levels [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. effect of anakinra/Kineret® on salivary cortisol, free urinary cortisol, and serum cortisol levels after an overnight dexamethasone suppression test [ Time Frame: 14 days ]
  2. correlation between the percentage of body fat or body mass index, and suppression of cortisol levels after injection of anakinra/Kineret® [ Time Frame: 14 days ]
  3. correlation between inflammatory parameters with cortisol levels [ Time Frame: 14 days ]
  4. 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. [ Time Frame: 14 days ]
    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.

  5. comparison of 1mg and 2mg dexamethasone suppression test [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227420


Locations
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Switzerland
University Hopsital Basel
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Mirjam Christ-Crain, MD, Prof. University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02227420     History of Changes
Other Study ID Numbers: EKNZ 2014-175
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents