Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-05 @ 7:33 AM
Study NCT ID:
NCT02072551
Status:
UNKNOWN
Last Update Posted:
2016-04-18
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2014-02-25', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean insulin secretion output', 'timeFrame': 'Week after inclusion'}], 'secondaryOutcomes': [{'measure': 'insulin secretion outout after arginine perfusion', 'timeFrame': 'during hospitalisation (3 days)'}, {'measure': 'sensitivity to insulin', 'timeFrame': 'during hospitalisation (3 days)'}, {'measure': 'glucago secretion output', 'timeFrame': 'during hospitalisation (3 days)'}]}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '32273272', 'type': 'DERIVED', 'citation': 'Le Bourgeois F, Beltrand J, Baz B, Julla JB, Riveline JP, Simon A, Flechtner I, Ait Djoudi M, Fauret-Amsellem AL, Vial Y, Scharfmann R, Sommet J, Boudou P, Cave H, Polak M, Gautier JF, Busiah K; TNDM Long-Term Follow-Up Study Group. Long-term Metabolic and Socioeducational Outcomes of Transient Neonatal Diabetes: A Longitudinal and Cross-sectional Study. Diabetes Care. 2020 Jun;43(6):1191-1199. doi: 10.2337/dc19-0324. Epub 2020 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetic people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 18 à 65 year\n* diabetic patient with a neonatal diabetis (before 1 year old) and need for insuline or patient with a relative having neonatal diabetis\n\nExclusion Criteria:\n\nDiabète induit (médicaments - ex corticoïdes) ou syndromique\n\n* infection\n* cancer\n* pegnancy'}, 'identificationModule': {'nctId': 'NCT02072551', 'acronym': 'GLUCONEO', 'briefTitle': 'Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Devenir au Long Cours de la Cellule bêta Chez Les Adultes Porteurs d'Anomalies génétiques à l'Origine du Diabète Néonatal", 'orgStudyIdInfo': {'id': 'GLUCONEO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult with neonatal diabetes', 'description': 'Adult with neonatal diabetes (before 1 year ) and need for insulin'}, {'label': 'non diabetic adults with a relative with neonatal diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Siant-louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}