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Completed

NCT Number: NCT02227420

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Hypersecretion; Cortisol Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hopsital Basel

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

Anakinra 100mg s.c. x 5

Primary outcomes

  1. Morning cortisol levels

    Time frame: 14 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: CortIL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2014
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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