Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 12:02 PM
Study NCT ID:
NCT01367106
Status:
UNKNOWN
Last Update Posted:
2017-12-21
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of "in UTERO" Exposure to Glucocorticoids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose Tolerance', 'timeFrame': '3 days', 'description': 'the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow'}], 'secondaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': '3 days'}, {'measure': 'Flow measurement of insulin secretory response to intravenous glucose', 'timeFrame': '3 days'}, {'measure': 'Measurement of the secretion of insulin and glucagon in response to arginine', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['offspring of 21-hydroxylase enzyme block'], 'conditions': ['21-hydroxylase; Defect']}, 'referencesModule': {'references': [{'pmid': '31665349', 'type': 'DERIVED', 'citation': 'Riveline JP, Baz B, Nguewa JL, Vidal-Trecan T, Ibrahim F, Boudou P, Vicaut E, Brac de la Perriere A, Fetita S, Breant B, Blondeau B, Tardy-Guidollet V, Morel Y, Gautier JF. Exposure to Glucocorticoids in the First Part of Fetal Life is Associated with Insulin Secretory Defect in Adult Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz145. doi: 10.1210/clinem/dgz145.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.', 'detailedDescription': 'The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult 23 subjects of exposed offspring will be compared to 23 controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years Aged\n* Males\n* Women of childbearing age with a reliable and effective contraception for over 2 months\n* Taking dexamethasone between the 6th and the 24th week of gestation by the mother with bloc 21-hydroxylase or normal pregnancy for control subjects\n* Normal blood pressure and heart rate measured at rest: systolic blood pressure \\<= 150 mmHg, diastolic blood pressure \\<= 90 mmHg, heart rate between 55 and 90 beats/mn.\n* Normal laboratory tests or not clinically significant abnormality NFS, platelets PT, aPTT, fibrin TP, TCA, Serum electrolytes, urea, creatinine Uric acid Triglycerides, total cholesterol, HDL cholesterol\n* Fating bood glucose \\<= 6.9 mmol/l (exclusion criteria for diabetes from the American Diabetes Association) during the OGTT.\n* Negative blood HCG\n* Accepting the constraints of the protocol and had signed informed and free consent.\n* Affiliated to the Social Security.\n\nExclusion Criteria:\n\n* Affected offspring of 21-hydroxylase enzyme block\n* Taking dexamethasone until pregnancy term by the mother of the subject\n* Type 2 diabetes in one of the two parents and/or 1 of the 4 grandparents\n* Pregnancy, Breastfeeding\n* Body Mass Index (weight/height2)\\> 50 kg/m2\n* Poisoning smoking (\\>10 cigarettes per day, whatever the duration of intoxication)\n* Any drug taken apart from minor analgesics (aspirin, paracetamol) for less than 8 days at the inclusion and oral contraception\n* Taking recent (less than 3 months) glucocorticoids either taken orally, by inhalation or percutaneously\n* Current infections or recent infections (\\<10 days)\n* Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological\n* Having donated blood or participated in a trial within 2 months preceding their inclusion'}, 'identificationModule': {'nctId': 'NCT01367106', 'acronym': 'GLUCODEX', 'briefTitle': 'Effects of "in UTERO" Exposure to Glucocorticoids', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)', 'orgStudyIdInfo': {'id': 'P081209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exposed offspring', 'interventionNames': ['Procedure: Euglycemic hyperinsulinemic clamp']}, {'type': 'OTHER', 'label': 'controls', 'interventionNames': ['Procedure: Euglycemic hyperinsulinemic clamp']}], 'interventions': [{'name': 'Euglycemic hyperinsulinemic clamp', 'type': 'PROCEDURE', 'description': 'Euglycemic hyperinsulinemic clamp will be performed at day 2', 'armGroupLabels': ['controls', 'exposed offspring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Professor GAUTIER', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-François GAUTIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}