Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT01285232
Status:
UNKNOWN
Last Update Posted:
2012-03-26
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Anakinra on Insulin Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053590', 'term': 'Interleukin 1 Receptor Antagonist Protein'}, {'id': 'D019947', 'term': 'Receptors, Interleukin-6'}], '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'}, {'id': 'D018123', 'term': 'Receptors, Interleukin'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .', 'timeFrame': 'after 4 weeks of treatment with anakinra'}], 'secondaryOutcomes': [{'measure': 'To determine the effect on anakinra on insulin sensitivity.', 'timeFrame': 'after 4 week treatment of anakinra', 'description': 'Oral glucose tolerance test'}, {'measure': 'Effects of anakinra on fat cell morphology and gene expression', 'timeFrame': 'after 4 weeks of treatment with anakinra', 'description': 'Fatbiopsy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glucose Intolerance', 'Impaired Insulin Secretion', 'Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.\n\nObjective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%\n* BMI \\>25 kg/m2\n* Age 40-70 years\n\nExclusion Criteria:\n\n* Known diabetes mellitus\n* Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%\n* Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)\n* Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)\n* Signs of current infection (fever, C-reactive protein \\>30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)\n* A history of recurrent infections\n* Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)\n* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range\n* Renal disease defined as MDRD \\< 60 ml/min/1.73m2\n* Neutropenia \\< 2x 109/L\n* Inability to understand the nature and extent of the trial and the procedures required.\n* Any medical condition that might interfere with the current study protocol\n* Participation in a drug trial within 60 days prior to the first dose'}, 'identificationModule': {'nctId': 'NCT01285232', 'briefTitle': 'The Effect of Anakinra on Insulin Secretion', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction', 'orgStudyIdInfo': {'id': 'Anakinra1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anakinra', 'description': 'Anakinra 150 mg/day during four weeks', 'interventionNames': ['Drug: Anakinra']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo during four weeks', 'interventionNames': ['Drug: Anakinra']}], 'interventions': [{'name': 'Anakinra', 'type': 'DRUG', 'otherNames': ['Kineret', 'Interleukin1-receptor antagonist'], 'description': '150 mg sc once daily during four weeks', 'armGroupLabels': ['Anakinra', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'C.J. Tack, MD, PhD, Prof. of Diabetology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}