Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05854251
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'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'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo controlled, double-blind, randomized, cross-over proof-of-concept study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insulin concentration following a standardized mixed-meal test', 'timeFrame': 'two time assessment at baseline and after 1-2 weeks', 'description': 'Changes in insulin concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.'}, {'measure': 'Change in glucose concentration following a standardized mixed-meal test', 'timeFrame': 'two time assessment at baseline and after 1-2 weeks', 'description': 'Changes in glucose concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.'}, {'measure': 'Change in c-peptide concentration following a standardized mixed-meal test', 'timeFrame': 'two time assessment at baseline and after 1-2 weeks', 'description': 'Changes in c-peptide concentration (nmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.'}, {'measure': 'Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test', 'timeFrame': 'two time assessment at baseline and after 1-2 weeks', 'description': 'Changes in insulinogenic index (IGI) (I30 - I0)/(G30 - G0) under anakinra compared to placebo.\n\nBlood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anakinra (Kineret®)'], 'conditions': ['Hyperinsulinemia', 'PreDiabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®).\n\nThe main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l.\n* BMI ≥ 28 kg/m2\n* Age ≥ 18 years\n* C-reactive protein ≥ 2 mg/dl\n* For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study\n\nExclusion Criteria:\n\n* Upper gastrointestinal surgery\n* Diagnosis of any type of diabetes mellitus\n* Signs of current infection\n* Use of any glucose lowering medication within the last three months\n* Use of investigational drug up to one week prior to start of treatment phase.\n* Anti-inflammatory medication, including systemic glucocorticoid therapy.\n* Neutropenia (leukocyte count \\< 1.5 × 109/L or absolute neutrophil count (ANC) \\< 0.5 × 109/L)\n* Anemia (hemoglobin \\< 11 g/dL for males, \\< 10 g/dL for females)\n* Clinically significant kidney or liver disease (creatinine \\> 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \\> 2 × ULN, alkaline phosphatase \\> 2 × ULN, or total bilirubin \\[tBili\\] \\> 1.5 × ULN)\n* Uncontrolled disease\n* Currently pregnant or breastfeeding\n* No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study'}, 'identificationModule': {'nctId': 'NCT05854251', 'acronym': 'Hyper-PreDIL', 'briefTitle': 'Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study', 'orgStudyIdInfo': {'id': '2023-00497; kt23Donath2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Intervention', 'description': 'Patients receive investigational product', 'interventionNames': ['Drug: Anakinra']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Intervention', 'description': 'Patients receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anakinra', 'type': 'DRUG', 'description': 'Subjects receive an s.c. injection of 100 mg Anakinra on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal', 'armGroupLabels': ['Experimental Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.67 ml of s.c. injection of saline will be taken on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal', 'armGroupLabels': ['Control Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Marc Donath, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}