Type 1 Diabetes and the Brain in Children
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 7 - 14 |
| Updated: | 7/11/2015 |
| Start Date: | March 2015 |
| Contact: | Kim Englert, BSN, RN |
| Email: | kimberly.englert@nemours.org |
| Phone: | 904-697-3056 |
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.
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.
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.
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
We found this trial at
5
sites
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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