Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06167616
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infections and Latent Autoimmune Diabetes in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071698', 'term': 'Latent Autoimmune Diabetes in Adults'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5048}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LADA', 'timeFrame': 'Up to 10 years', 'description': '≥35 years at diagnosis, GADA positivity (≥10 U/ml) and C-peptide concentrations of ≥0.2 nmol/L (IMMULITE) or ≥0.3 nmol/L (Cobas).'}], 'secondaryOutcomes': [{'measure': 'Type 2 diabetes', 'timeFrame': 'Up to 10 years', 'description': 'also ≥35, GADA negative and had C-peptide concentrations of \\>0.60 (IMMULITE)/\\>0.72 (Cobas) nmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latent Autoimmune Diabetes in Adults', 'Infections', 'Diabetes Mellitus', 'Type 2 diabetes', 'Case-Control Studies', 'register study'], 'conditions': ['Latent Autoimmune Diabetes in Adults', 'Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ki.se/en/imm/estrid', 'label': 'ESTRID website'}]}, 'descriptionModule': {'briefSummary': 'Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.', 'detailedDescription': 'The investigators will use data from a population-based Swedish case-control study (ESTRID) with incident cases of LADA (n=597) and matched controls (n=2386). History of infectious disease are ascertained through national and regional patient registers. The investigators will estimate adjusted odds ratios (OR) with 95% CI for ≥1 respiratory (any/upper/lower), gastrointestinal, herpetic, other or any infectious disease episode, or separately, for 1 and ≥2 infectious disease episodes, within 0-1, 1-3, 3-5 and 5-10 years before LADA diagnosis/matching. Stratified analyses will be performed based on HLA risk genotypes and GADA levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '35 years or older, residing in Scania or Uppsala county.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 35 years or older, residing in Scania or Uppsala county.\n\nExclusion Criteria:\n\n* Less than 35 years'}, 'identificationModule': {'nctId': 'NCT06167616', 'acronym': 'LADA', 'briefTitle': 'Infections and Latent Autoimmune Diabetes in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Infections and Genetic Susceptibility in LADA and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2022-00811_1'}, 'secondaryIdInfos': [{'id': '2018-03035', 'type': 'OTHER_GRANT', 'domain': 'Swedish Research Council'}, {'id': '2018-00337', 'type': 'OTHER_GRANT', 'domain': 'FORTE'}, {'id': 'NNF19OC0057274', 'type': 'OTHER_GRANT', 'domain': 'Novo Nordisk Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'LADA', 'description': 'Classification of LADA based on age ≥35 years at diagnosis, GADA positivity (≥10 U/ml) and C-peptide concentrations of ≥0.2 nmol/L (IMMULITE) or ≥0.3 nmol/L (Cobas).'}, {'label': 'Type 2 diabetes', 'description': '≥35 years, GADA negative and C-peptide concentrations of \\>0.60 (IMMULITE)/\\>0.72 (Cobas) nmol/L.'}, {'label': 'Controls', 'description': '≥35 years, free of diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sofia Carlsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}, {'name': 'Swedish Council for Working Life and Social Research', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sofia Carlsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}