Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-29 @ 4:10 AM
Study NCT ID:
NCT03309761
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'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': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2017-10-05', 'studyFirstSubmitQcDate': '2017-10-10', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cluster of Differentiation 4 (CD4+) T cell subpopulations', 'timeFrame': 'Day 0', 'description': 'immunosenescence; number/mm3'}, {'measure': 'Cluster of Differentiation 8 (CD8+) T cell subpopulations', 'timeFrame': 'Day 0', 'description': 'immunosenescence; number/mm3'}, {'measure': 'B cell subpopulations', 'timeFrame': 'Day 0', 'description': 'flow cytometry'}, {'measure': 'Natural killer (NK) cell subpopulations', 'timeFrame': 'Day 0', 'description': 'immunosenescence; number/mm3'}, {'measure': 'sCD14 level', 'timeFrame': 'Day 0', 'description': 'ng/ml, enzyme-linked immunosorbent assays (ELISA)'}, {'measure': '16 ribosomal ribonucleic acid (rRNA) levels', 'timeFrame': 'Day 0', 'description': 'polymerase chain reaction (PCR); copies/µl'}, {'measure': 'lipopolysaccharide (LPS)-binding protein level', 'timeFrame': 'Day 0', 'description': 'ELISA; µg/mL'}, {'measure': 'Intestinal Fatty Acid Binding Protein level', 'timeFrame': 'Day 0', 'description': 'ELISA; pg/mL'}, {'measure': 'Total cholesterol', 'timeFrame': 'Day 0', 'description': 'mM/L'}, {'measure': 'High Density Lipoprotein', 'timeFrame': 'Day 0', 'description': 'mM/L'}, {'measure': 'Low Density Lipoprotein', 'timeFrame': 'Day 0', 'description': 'mM/L'}, {'measure': 'fasting glycemia', 'timeFrame': 'Day 0'}, {'measure': 'fasting insulinemia', 'timeFrame': 'Day 0', 'description': 'mIU/L'}, {'measure': 'γ-glutamyl transpeptidase level', 'timeFrame': 'Day 0'}, {'measure': 'glutamic pyruvic transaminase', 'timeFrame': 'Day 0'}, {'measure': 'hip circumference', 'timeFrame': 'Day 0', 'description': 'cm'}, {'measure': 'waist circumference', 'timeFrame': 'Day 0', 'description': 'cm'}, {'measure': 'minimal arterial tension', 'timeFrame': 'Day 0', 'description': 'mmHg'}, {'measure': 'maximal arterial tension', 'timeFrame': 'Day 0', 'description': 'mmHg'}, {'measure': 'Cluster of Differentiation 163 (CD163) level', 'timeFrame': 'Day 0', 'description': 'ng/ml, enzyme-linked immunosorbent assays (ELISA)'}, {'measure': 'soluble tumor necrosis factor-alpha receptor I (sTNFRI) level', 'timeFrame': 'Day 0', 'description': 'ng/ml, enzyme-linked immunosorbent assays (ELISA)'}, {'measure': 'soluble endothelial protein C Receptro (sEPCR) level', 'timeFrame': 'Day 0', 'description': 'ng/ml, enzyme-linked immunosorbent assays (ELISA)'}, {'measure': 'tissue plasminogen activator (tPa) level', 'timeFrame': 'Day 0', 'description': 'ng/ml, enzyme-linked immunosorbent assays (ELISA)'}], 'secondaryOutcomes': [{'measure': 'Prevalence of insulin and metabolic syndrome', 'timeFrame': 'Day 0', 'description': '% subjects'}, {'measure': 'Link between immune activation profile and other features of metabolic syndrome', 'timeFrame': 'Day 0', 'description': 'logistic regression of individual markers'}, {'measure': 'Immune activation linked to the profile', 'timeFrame': 'Day 0', 'description': 'logistic regression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '33257766', 'type': 'RESULT', 'citation': 'Cezar R, Winter A, Desigaud D, Pastore M, Kundura L, Dupuy AM, Cognot C, Vincent T, Reynes C, Dunyach-Remy C, Lavigne JP, Sabatier R, Le Merre P, Maggia E, Corbeau P. Identification of distinct immune activation profiles in adult humans. Sci Rep. 2020 Nov 30;10(1):20824. doi: 10.1038/s41598-020-77707-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers aged between 55-69', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has been informed of the study, its objectives, constraints and the patient rights\n* The patient must have given their free and informed consent and signed the consent form\n* The patient is aged 55-69\n\nExclusion Criteria:\n\n* The subject is participating in an interventional category 1 study\n* The patient has participated in another category 1 interventional study in the last 3 months\n* The patient is in a period of exclusion determined by a previous study\n* The patient is under safeguard of justice or state guardianship\n* The subject refuses to sign the consent\n* The subject does not understand the information'}, 'identificationModule': {'nctId': 'NCT03309761', 'acronym': 'METACTIV', 'briefTitle': 'Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69', 'orgStudyIdInfo': {'id': 'NIMAO/2016-02/PC-01'}, 'secondaryIdInfos': [{'id': '2017-A01504-49', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients aged 55-60', 'interventionNames': ['Other: Blood test']}], 'interventions': [{'name': 'Blood test', 'type': 'OTHER', 'description': '6ml blood sample taken', 'armGroupLabels': ['Patients aged 55-60']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Nîmes', 'country': 'France', 'facility': "Centre d'examen de santé de la Sécurité Sociale de Nîmes", 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}