Type 1 Diabetes and the Brain in Children

Nemours Children's Health

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT02351466

588973

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 221 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

221 participants in 2 patient groups

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.

Treatment:

Other: Observational

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.

Treatment:

Other: Observational