Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02351466
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 1 Diabetes and the Brain in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in total and regional gray and white matter volumes and white matter microstructure.', 'timeFrame': '2 years', 'description': 'Structural MRIs of children with T1 diabetes will be compared to age- and sex-matched, non-diabetic healthy controls. We will investigate whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty. The present cohorts (T1D and controls) of young children will be followed for 2 more years with similar studies repeated 2 years apart. Overall glycemic profiles will continue to be obtained every 3 months longitudinally between scans with CGM and HbA1c for children with Type 1 Diabetes.'}], 'secondaryOutcomes': [{'measure': 'Measures of activation of frontal-parietal networks and functional connectivity of resting state networks using blood oxygen level dependent (BOLD)-functional MRI.', 'timeFrame': '2 years'}, {'measure': 'Changes in Neurocognitive metrics including IQ as well as executive and visual-spatial memory.', 'timeFrame': '2 years', 'description': 'We will perform neurocognitive metrics reflecting frontal, parietal-occipital and hippocampal function. Children with T1D will be followed longitudinally and compared with controls to determine whether these differences are associated with measures of glycemic control.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brain Growth and Development', 'Cognition', 'Children', 'Continuous Glucose Monitoring', 'MRI', 'Functional MRI'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '25488901', 'type': 'BACKGROUND', 'citation': 'Mauras N, Mazaika P, Buckingham B, Weinzimer S, White NH, Tsalikian E, Hershey T, Cato A, Cheng P, Kollman C, Beck RW, Ruedy K, Aye T, Fox L, Arbelaez AM, Wilson D, Tansey M, Tamborlane W, Peng D, Marzelli M, Winer KK, Reiss AL; Diabetes Research in Children Network (DirecNet). Longitudinal assessment of neuroanatomical and cognitive differences in young children with type 1 diabetes: association with hyperglycemia. Diabetes. 2015 May;64(5):1770-9. doi: 10.2337/db14-1445. Epub 2014 Dec 8.'}, {'pmid': '24512675', 'type': 'BACKGROUND', 'citation': 'Cato MA, Mauras N, Ambrosino J, Bondurant A, Conrad AL, Kollman C, Cheng P, Beck RW, Ruedy KJ, Aye T, Reiss AL, White NH, Hershey T; Diabetes Research in Children Network (DirecNet). Cognitive functioning in young children with type 1 diabetes. J Int Neuropsychol Soc. 2014 Feb;20(2):238-47. doi: 10.1017/S1355617713001434.'}, {'pmid': '24319123', 'type': 'BACKGROUND', 'citation': 'Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6.'}, {'pmid': '24170697', 'type': 'BACKGROUND', 'citation': 'Marzelli MJ, Mazaika PK, Barnea-Goraly N, Hershey T, Tsalikian E, Tamborlane W, Mauras N, White NH, Buckingham B, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Neuroanatomical correlates of dysglycemia in young children with type 1 diabetes. Diabetes. 2014 Jan;63(1):343-53. doi: 10.2337/db13-0179. Epub 2013 Oct 29.'}, {'pmid': '24096802', 'type': 'BACKGROUND', 'citation': 'Barnea-Goraly N, Weinzimer SA, Ruedy KJ, Mauras N, Beck RW, Marzelli MJ, Mazaika PK, Aye T, White NH, Tsalikian E, Fox L, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner--the Diabetes Research in Children Network (DirecNet) experience. Pediatr Radiol. 2014 Feb;44(2):181-6. doi: 10.1007/s00247-013-2798-7. Epub 2013 Oct 6.'}, {'pmid': '25496062', 'type': 'BACKGROUND', 'citation': 'Tansey M, Beck R, Ruedy K, Tamborlane W, Cheng P, Kollman C, Fox L, Weinzimer S, Mauras N, White NH, Tsalikian E; Diabetes Research in Children Network (DirecNet). Persistently high glucose levels in young children with type 1 diabetes. Pediatr Diabetes. 2016 Mar;17(2):93-100. doi: 10.1111/pedi.12248. Epub 2014 Dec 11.'}, {'pmid': '33568403', 'type': 'DERIVED', 'citation': 'Mauras N, Buckingham B, White NH, Tsalikian E, Weinzimer SA, Jo B, Cato A, Fox LA, Aye T, Arbelaez AM, Hershey T, Tansey M, Tamborlane W, Foland-Ross LC, Shen H, Englert K, Mazaika P, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Impact of Type 1 Diabetes in the Developing Brain in Children: A Longitudinal Study. Diabetes Care. 2021 Apr;44(4):983-992. doi: 10.2337/dc20-2125. Epub 2021 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have previously studied a group of young children with T1D using brain MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18 months. The investigators observed significant differences in gray matter volumes and white matter microstructure in the children with diabetes as compared to controls. These differences appeared to increase over time, with slower rates of brain growth in the T1D group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et al, Diabetes 2015). In this new protocol the investigators will include the same children with T1D and healthy controls previously studied and recruit new similar subjects to replace those lost by attrition. The investigators will be using structural and functional brain MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the brain persist or worsen over longitudinal follow up, and whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty.', 'detailedDescription': 'Study participation will last about 2 to 2 1/12 years and will include a brain MRI without sedation, as well as a functional MRI and neurocognitive testing. The children with T1D will wear a continuous glucose monitor (CGM), will follow up every 3 months and will be asked to wear the CGM each time. The structural and functional MRI and neurocognitive testing will be repeated 2 yrs from baseline.\n\nThe healthy controls will also undergo MRI and cognitive testing as well as have a blood sample at baseline and after 2 years.\n\nParents of newly recruited subjects will also have abbreviated IQ testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with Type 1 Diabetes or Healthy non-diabetic controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for T1 Diabetes Group:\n\n* Diabetes diagnosed after age 6 months\n* Gestational age \\>34 weeks, birth weight \\>2kg\n\nInclusion Criteria for Healthy Control Group:\n\n* Normal HbA1C and fasting blood glucose\n* Negative diabetes auto-antibodies (those that are siblings of T1D patients)\n* Gestational age \\>34 weeks, birth weight \\>2kg\n\nExclusion Criteria for Both Groups:\n\n* History of mental retardation, language or learning disability\n* Known genetic or medical problem that could impair brain development\n* Abnormality of the brain/nervous system, visual or hearing problem\n* History of seizures not associated with fever\n* Previous inpatient psychiatric treatment\n* Unable to have a MRI of the head due to metal appliances'}, 'identificationModule': {'nctId': 'NCT02351466', 'briefTitle': 'Type 1 Diabetes and the Brain in Children', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Type 1 Diabetes and the Brain in Children: Metabolic Interventions. Protocol #1: Longitudinal Assessment', 'orgStudyIdInfo': {'id': '588973'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with Type 1 Diabetes', 'description': 'Subjects with T1 diabetes will undergo a physical exam and blood test as well as structural and functional brain MRI, neurocognitive testing and wear a continuous glucose monitor every 3 months for 24 months.', 'interventionNames': ['Other: Observational']}, {'label': 'Healthy Controls', 'description': 'Subjects will undergo a physical exam and blood test as well as structural and functional brain MRI at baseline and after 24 months.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'armGroupLabels': ['Children with Type 1 Diabetes', 'Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Childrens Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '63126', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Nelly Mauras, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Clinic"}, {'name': 'Allan L Reiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}, {'name': 'University of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nelly Mauras', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}