Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT05764850
Status:
RECRUITING
Last Update Posted:
2023-03-13
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Type 1 Diabetes Endophenotypes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D000096442', 'term': 'Genetic Risk Score'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cluster analysis to decipher underlying mechanisms of type 1 diabetes', 'timeFrame': 'blood sampling and analyses', 'description': 'We will combine clinical, laboratory, genetic, transcriptomic, and metabolomic datasets of an extensively phenotyped cohort of type 1 diabetes patients (Children and young adults).\n\nWe will create clinical and genetic correlates with the following clinical parameters: Age at diabetes onset (years), disease duration (years), BMI (kg/m2), diabetes autoantibodies, C-peptide level (pmol/l) and decline over time, HbA1c (%), insulin dose (U/kg/d), ketoacidosis at disease onset (y/n), lipid levels (Total cholesterol, triglycerides, HLD, LDL, Lipoprotein(a)), macro- and microvascular complications, ethnicity, family history for diabetes, associated autoimmune diseases (e.g., autoimmune thyroiditis or celiac disease) and mixed meal tolerance test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes mellitus', 'Children', 'Adolescent', 'Young adult', 'Genetic', 'Transcriptomic', 'Metabolomic', 'Lipidomic', 'Genetic risk score'], 'conditions': ['Type 1 Diabetes Mellitus', 'Genetic Predisposition to Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study consists of performing cluster analysis to decipher underlying disease mechanisms of type 1 diabetes in children and young adults.\n\nTo this end, we will combine clinical, laboratory, genetic, transcriptomic, and metabolomic datasets of an extensively phenotyped cohort of children and young adults with type 1 diabetes. We will also assess the risk for cardiovascular diseases in this most vulnerable diabetes cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, adolescents, and young adults followed at the pediatric diabetology unit of the University Hospital of Geneva.\n\nControls Children, adolescents, and young adults coming for a routine blood sample at University Hospital of Geneva', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (Type 1 Diabetic patients):\n\n* Informed consent as documented by signature\n* Patient's age: between 0 and 25 years old.\n* Children, adolescents, and young adult patients followed in diabetology.\n\nExclusion Criteria (Type 1 Diabetic patients):\n\n* No exclusion criteria\n\nInclusion Criteria (Controls):\n\n* Informed consent as documented by signature\n* Patient's age: 25 less than 6 years of age and 25 between 6 and 25 years old.\n* Healthy patient\n\nExclusion Criteria (Controls):\n\n* Patient receiving treatment affecting metabolic control (ex: systemic corticoids, beta blocker, immunotherapy etc.)\n* Concomitant disease that may affect the analysis of the results (ex: cancer, active autoimmune disease requiring treatment)"}, 'identificationModule': {'nctId': 'NCT05764850', 'acronym': 'METYDIA', 'briefTitle': 'Mechanisms of Type 1 Diabetes Endophenotypes', 'organization': {'class': 'OTHER', 'fullName': 'Pediatric Clinical Research Platform'}, 'officialTitle': 'Mechanisms of Type 1 Diabetes Endophenotypes, by Cluster Analysis', 'orgStudyIdInfo': {'id': '2022-02119'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': '100 patients followed in pediatric diabetology at the university hospital of Geneva: a cohort', 'interventionNames': ['Genetic: Genome sequencing']}, {'label': 'Control', 'description': '50 control patients', 'interventionNames': ['Genetic: Genome sequencing']}], 'interventions': [{'name': 'Genome sequencing', 'type': 'GENETIC', 'otherNames': ['Lipidomic', 'Metabolomic', 'Transcriptomic', 'Mixed meal tolerance test'], 'description': '100 extensively phenotyped pediatric and young adult patients for genotyping, metabolomic and lipidomic analyses. Polygenic risk scores for type 1 diabetes and cardiovascular disease will be performed.\n\nFor patients older than 6 years who agree to do a second visit (optional), a Mixed Meal Tolerance Test (MMTT: the gold standard for assessing beta cell function) will be done as well as transcriptomic analysis.', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Valerie VS Schwitzgebel, MD', 'role': 'CONTACT', 'email': 'valerie.schwitzgebel@unige.ch', 'phone': '+41 22 372 45 90'}, {'name': 'Fanny FL Iafrate Luterbacher, MD', 'role': 'CONTACT', 'email': 'fanny.luterbacher@hcuge.ch', 'phone': '+41 78 603 06 92'}, {'name': 'Valerie VS Schwitzgebel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fanny FL Iafrate Luterbacher, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Valerie VS Schwitzgebel, MD', 'role': 'CONTACT', 'email': 'valerie.schwitzgebel@unige.ch', 'phone': '+41 22 372 45 90'}, {'name': 'Fanny FL Iafrate-Luterbacher, MD', 'role': 'CONTACT', 'email': 'fanny.luterbacher@hcuge.ch', 'phone': '+41 78 603 06 92'}], 'overallOfficials': [{'name': 'Valerie VS Schwitzgebel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Geneva / University of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatric Clinical Research Platform', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}