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Type 1 Diabetes and the Brain in Children
Recruiting
Trial ID: NCT02351466
Purpose
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.
Official Title
Type 1 Diabetes and the Brain in Children: Metabolic Interventions. Protocol #1: Longitudinal Assessment
Stanford Investigator(s)
Eligibility
Inclusion Criteria for T1 Diabetes Group:
- Diabetes diagnosed after age 6 months
- Gestational age >34 weeks, birth weight >2kg
Inclusion Criteria for Healthy Control Group:
- Normal HbA1C and fasting blood glucose
- Negative diabetes auto-antibodies (those that are siblings of T1D patients)
- Gestational age >34 weeks, birth weight >2kg
Exclusion Criteria for Both Groups:
- History of mental retardation, language or learning disability
- Known genetic or medical problem that could impair brain development
- Abnormality of the brain/nervous system, visual or hearing problem
- History of seizures not associated with fever
- Previous inpatient psychiatric treatment
- Unable to have a MRI of the head due to metal appliances
Intervention(s):
other: Observational
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305