Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-01 @ 10:12 PM
Study NCT ID:
NCT04010903
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cohort of subjects with/without overweight and with/without insulin resistance'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between urinary levels of BCAAs and HOMA index', 'timeFrame': 'through study completion, an average of two years and a half', 'description': 'Identification of urinary BCAAs as markers of insulin resistance'}], 'secondaryOutcomes': [{'measure': 'Correlation between blood and urine BCAAs levels', 'timeFrame': 'through study completion, an average of two years and a half', 'description': 'Validation of urinary BCAAs as biomarkers of insulin resistance'}, {'measure': 'Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method', 'timeFrame': 'through study completion, an average of two years and a half', 'description': 'Measured by enzymatic method (artificial vesicles) and classic method (standard LC-MS/MS)'}, {'measure': 'Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index', 'timeFrame': 'through study completion, an average of two years and a half', 'description': 'Measured by enzymatic method (artificial vesicles) and HOMA index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INSULIN RESISTANCE'], 'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index.\n\nBlood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance.\n\nIdentification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed.\n\nCorrelations between mass spectometry and the innovative detection method of BCAAs will be searched.', 'detailedDescription': 'Blood and urine samples will be collected in 330 persons to assess BCAAs levels and correlate them with HOMA index.\n\nPersons included will be:\n\n110 persons with BMI\\>27 and HOMA \\>4 with no diabetes 110 persons with BMI\\>27 and HOMA \\< 4 with no diabetes 110 persons with BMI \\< 27 and HOMA \\<4 with no diabetes, including at least 50 men and 50 women, 30 aged 18-35, 30 aged 36-55, 30 aged 56-75.\n\nUrine BCAAs will be measured by both mass spectrometry and the innovative method based on synthetic biology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no diabetes\n* according to studied subpopulations: BMI\\<27 and HOMA \\<4, BMI\\>27 and HOMA\\>4, BMI\\>27 and HOMA\\<4\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* active or suspected chronic infection\n* treatment affecting insulin sensitivity'}, 'identificationModule': {'nctId': 'NCT04010903', 'acronym': 'BIOMUIR', 'briefTitle': 'Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance', 'orgStudyIdInfo': {'id': '19_0077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEALTHY SUBJECTS', 'description': 'SUBJECTS WITH BMI\\<27 and HOMA\\<4', 'interventionNames': ['Diagnostic Test: assessment of biomarkers of insulin resistance']}, {'type': 'EXPERIMENTAL', 'label': 'OVERWEIGHT NON INSULINRESISTANT PATIENTS', 'description': 'SUBJECTS WITH BMI\\>27 and HOMA\\<4', 'interventionNames': ['Diagnostic Test: assessment of biomarkers of insulin resistance']}, {'type': 'EXPERIMENTAL', 'label': 'OVERWEIGHT INSULINRESISTANT PATIENTS', 'description': 'SUBJECTS WITH BMI\\>27 and HOMA\\>4', 'interventionNames': ['Diagnostic Test: assessment of biomarkers of insulin resistance']}], 'interventions': [{'name': 'assessment of biomarkers of insulin resistance', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood and urine sample collection for assays of BCAAs', 'armGroupLabels': ['HEALTHY SUBJECTS', 'OVERWEIGHT INSULINRESISTANT PATIENTS', 'OVERWEIGHT NON INSULINRESISTANT PATIENTS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'EMILIE BARDE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}, {'name': 'Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}