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Type 1 Diabetes and the Brain in Children: Metabolic Interventions. Protocol #1: Longitudinal Assessment
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.
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. The healthy controls will also undergo MRI and cognitive testing as well as have a blood sample at baseline and after 2 years. Parents of newly recruited subjects will also have abbreviated IQ testing.
Age
7 - 16 years
Sex
ALL
Healthy Volunteers
Yes
Stanford University
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
Nemours Childrens Clinic
Jacksonville, Florida, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Washington University
St Louis, Missouri, United States
Start Date
March 1, 2015
Primary Completion Date
November 1, 2018
Completion Date
December 1, 2018
Last Updated
October 22, 2020
221
ACTUAL participants
Observational
OTHER
Lead Sponsor
Nemours Children's Clinic
Collaborators
NCT04786262
NCT06748963
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06325202