Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-13 @ 11:48 AM
Study NCT ID:
NCT06117358
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Pre-Diabetes in Overweight and Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate', 'timeFrame': 'Baseline', 'description': 'determine the prevalence of prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors through many investigations as HbA1c , Fasting blood glucose level , Lipid profile in 150 obese children.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Diabetes']}, 'descriptionModule': {'briefSummary': 'Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.', 'detailedDescription': 'Childhood obesity has reached epidemic levels in developed as well as in developing countries, Overweight and obesity in childhood have significant impact on both physical and psychological health.\n\nChildhood obesity has been linked to numerous medical conditions. These conditions include : fatty liver disease, sleep apnea, Type 2 diabetes, asthma, cardiovascular disease, high cholesterol, cholelithiasis (gallstones), glucose intolerance and insulin resistance, etc.\n\nObesity is associated with Prediabetes , a significant risk factor for development of type 2 diabetes mellitus T2DM and its accompanying complications.\n\nIn some populations, type 2 diabetes is now the dominant form of diabetes in children and adolescents.\n\nPrediabetes is defined by a fasting glucose level of 100 to 125 mg/dL , glycated hemoglobin level (HbA1C) of 5.7% to 6.4% , or a glucose level of 140 to 199 mg/dL measured 2 hours after a 75-g oral glucose load. approximately 10% of people with prediabetes progress to having diabetes each year.\n\nThe vast majority of pediatric cases occur after age 10, with the peak age for presentation occurring at mid-puberty (approximately age 14 years).\n\nThe ADA recommends screening for type 2 diabetes in children after onset of puberty or age 10 years who are overweight (BMI ≥85th percentile) or obese (BMI ≥95th percentile) and have one or more additional risk factors for diabetes.\n\nOne report in JAMA Pediatrics found that nearly one in three adolescents and teens has prediabetes and the rate among 12 to 19 year-olds more than doubled between 1999-2002 and 2015-2018, jumping from 12 percent to 28 percent.\n\nHowever , no enough data are available regarding prevalence and risk factors of prediabetes in overweight and obese youth particularly in our locality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• obese and overweight children and adolescents in Assiut governorate aged between (10-18) years.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes , aged (10-18) years.\n* Body mass index calculated as weight in Kg/(height in meters)2 :\n\n * Over weight \\> 85% percentile\n * Obese \\> 95% percentile " On Egyptian growth chart "\n\nExclusion Criteria:\n\n* • Children and adolescents with type 2 diabetes mellitus.\n\n * Children and adolescents with drug history affecting blood glucose level as corticosteroids.\n * Children and adolescents with any condition affecting blood glucose level as Cushing disease.'}, 'identificationModule': {'nctId': 'NCT06117358', 'briefTitle': 'Detection of Pre-Diabetes in Overweight and Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Detection of Pre-Diabetes in Overweight and Obese Children and Adolescents in Assiut Governorate', 'orgStudyIdInfo': {'id': 'Detection of Pre-Diabetes'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER', 'description': 'Descriptive cross section study'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmouud Bakr', 'role': 'CONTACT', 'email': 'mahmoudbakr423@gmail.com', 'phone': '+201067094097'}, {'name': 'Hanaa Abedllateef', 'role': 'CONTACT', 'email': 'Hae50@.aun.edu.com', 'phone': '01064747613'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahmoud Bakr Gaber', 'investigatorAffiliation': 'Assiut University'}}}}