Status:
COMPLETED
Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-11 years
Brief Summary
The proposed project will assess hypothesized risk factors (age of onset, Diabetic ketoacidosis (DKA) at presentation and glycemic control), as well as potentially modifiable protective factors (child...
Detailed Description
The onset of type 1 diabetes (T1D) in childhood results in clinically significant deficits in neurocognitive functioning that manifest in adulthood. These deficits have implications for adaptive funct...
Eligibility Criteria
Inclusion
- Pediatric T1D sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
- are between 6 -11 years of age
- have no history of afebrile seizure (not related to hypoglycemia) or sleep disorders other than insufficient sleep or insomnia
- no contraindications to high quality MRI of the brain (no metal implants or braces)
- no premature birth (\<34 weeks) or low birth weight (\<2,000g).
- Comparison sample: Children will be eligible if they meet the following inclusion/exclusion criteria:
- no known chronic medical conditions or intellectual disability
- no known history of concussion or traumatic brain injury
- no history of afebrile seizure; (4) no braces or metal implants
- (5) no premature birth (\<34 weeks) or low birth weight (\<2,000g).
- Parents or primary caregivers of all children will be eligible if they:
- live with the child
- read/speak English to allow use of validated parental questionnaires. The parent who is the primary caregiver of the child will be invited to participate.
Exclusion
- N/A
Key Trial Info
Start Date :
January 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04135365
Start Date
January 18 2021
End Date
October 31 2022
Last Update
November 1 2022
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232