- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135365
Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
Identifying Modifiable Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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 Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric T1D
A sample of 20 children with Type 1 Diabetes and their caregivers will be asked to stay after their diabetes clinic appointment to complete enrollment, or they may choose to come back for a study visit.
Trained study staff will describe the study in detail to interested families.
They will be encouraged to ask questions before giving consent.
After obtaining informed consent/assent, children and caregivers will schedule time for a neurocognitive assessment and neuroimaging assessment.
Children and caregivers will complete assessments again approximately 12 months later.
|
Observational study therefore there are no interventions
Observational study therefore there are no interventions
|
Comparison
Children with no known chronic medical conditions or intellectual disability will undergo the same procedure listed for the Pediatric T1D group
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Observational study therefore there are no interventions
Observational study therefore there are no interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function: Full-scale IQ
Time Frame: 12 months
|
To assess cognitive differences in full-scale IQ using the Wechsler Intelligence Scale for Children, fifth edition (WISC V) in children with T1D vs. comparison children.
The Full-Scale IQ is an estimate of overall intellectual ability.
The WISC-V takes approximate 48 minutes to administer.
The FSQI uses a standard score metric with a mean of 100 and an Standard Deviation of 15.
|
12 months
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Cognitive Function: Executive Function
Time Frame: 12 monnths
|
To assess cognitive differences in executive function using the The NIH Toolbox Executive Function Tests in children with T1D vs. comparison children. 1) NIH Flanker Inhibitory Control and Attention Test will be used to assess children's ability to inhibit visual attention. Average administration time is 4 minutes. A scoring algorithm integrates accuracy, a suitable measure in early childhood, yielding scores from 0 to 10. |
12 monnths
|
Cognitive Function: Behavior Rating Inventory of Executive Function, Second Edition
Time Frame: 12 months
|
Parent report of child's executive function, has been validated for use in children ages 5-18 years.
Scaled T-scores are based on normative data for age and sex.
The BRIEF2 consists of 63 items, and it yields a Global Executive Composite score, as well as a Behavior Regulation Index, Emotional Regulation Index, and Cognitive Regulation Index
|
12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging
Time Frame: 12 months
|
Differences in brain volume and white matter microstructure in children with T1D vs comparison children.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lori Jordan, MD, PhD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1DCohortStudy
- 1U34DK123895-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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