Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02227420
Status:
COMPLETED
Last Update Posted:
2016-08-23
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of IL-1 Beta on the HPA-axis in Obese Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053590', 'term': 'Interleukin 1 Receptor Antagonist Protein'}], 'ancestors': [{'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morning cortisol levels', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'effect of anakinra/Kineret® on salivary cortisol, free urinary cortisol, and serum cortisol levels after an overnight dexamethasone suppression test', 'timeFrame': '14 days'}, {'measure': 'correlation between the percentage of body fat or body mass index, and suppression of cortisol levels after injection of anakinra/Kineret®', 'timeFrame': '14 days'}, {'measure': 'correlation between inflammatory parameters with cortisol levels', 'timeFrame': '14 days'}, {'measure': '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.', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'comparison of 1mg and 2mg dexamethasone suppression test', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Hypersecretion; Cortisol']}, 'referencesModule': {'references': [{'pmid': '32275191', 'type': 'DERIVED', 'citation': 'Urwyler SA, Ebrahimi F, Burkard T, Schuetz P, Poglitsch M, Mueller B, Donath MY, Christ-Crain M. IL (Interleukin)-1 Receptor Antagonist Increases Ang (Angiotensin [1-7]) and Decreases Blood Pressure in Obese Individuals. Hypertension. 2020 Jun;75(6):1455-1463. doi: 10.1161/HYPERTENSIONAHA.119.13982. Epub 2020 Apr 10.'}, {'pmid': '28962047', 'type': 'DERIVED', 'citation': 'Urwyler SA, Cupa N, Christ-Crain M. Comparison of 1 mg versus 2 mg Dexamethasone Suppression Test in Patients with Obesity. Horm Metab Res. 2017 Nov;49(11):854-859. doi: 10.1055/s-0043-119128. Epub 2017 Sep 29.'}, {'pmid': '28324042', 'type': 'DERIVED', 'citation': 'Urwyler SA, Schuetz P, Ebrahimi F, Donath MY, Christ-Crain M. Interleukin-1 Antagonism Decreases Cortisol Levels in Obese Individuals. J Clin Endocrinol Metab. 2017 May 1;102(5):1712-1718. doi: 10.1210/jc.2016-3931.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* BMI \\>30kg/m2 and at least 1 manifestations of the metabolic syndrome (i.e. diabetes/ prediabetes, hypertension, dyslipidemia)\n* Willingness to use contraceptive measures adequate to prevent becoming pregnant\n\nExclusion Criteria:\n\n* Medication with glucocorticosteroids\n* Known Cushing Syndrome\n* Pregnancy or breast feeding\n* Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months\n* Hematologic disease (leukocyte count \\< 1.5x109/l, hemoglobin \\<11 g/dl, platelets \\<100 x 103/ul)\n* Kidney disease (creatinine-clearance \\< 30ml/min))\n* Liver disease (transaminases \\>4x upper normal range)\n* Active carcinoma\n* History of tuberculosis\n* Alcohol consumption \\>40g/d for men, \\>30g/d for women\n* Known allergy towards anakinra\n* Subject refusing or unable to give written informed consent'}, 'identificationModule': {'nctId': 'NCT02227420', 'acronym': 'CortIL', 'briefTitle': 'Effects of IL-1 Beta on the HPA-axis in Obese Persons', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Effects of IL-1 Beta on the Hypothalamic-pituitary-adrenal (HPA) Axis in Obese Persons - the CortIL-Study', 'orgStudyIdInfo': {'id': 'EKNZ 2014-175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anakinra', 'description': 'Anakinra 100mg s.c. x 5', 'interventionNames': ['Drug: Anakinra']}], 'interventions': [{'name': 'Anakinra', 'type': 'DRUG', 'description': 'Anakinra 100mg s.c. x 5', 'armGroupLabels': ['Anakinra']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hopsital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}