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NCT02351466 · ClinicalTrials.gov registry record
Type 1 Diabetes and the Brain in Children
A clinical trial, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- 221
- Enrollment target
NCT02351466: Completed study, sponsored by Nemours Children's Clinic.
NCT02351466 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 221 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02351466 has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- 221 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Structural MRIs of children with T1 diabetes will be compared to age- and sex-matched, non-diabetic healthy controls. We will investigate whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty. The present cohorts (T1D and controls) of young children will be followed for 2 more years with similar studies repeated 2 years apart. Overall glycemic profiles will continue to be obtained every 3 months longi
Interventions
- OTHER Observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-12 |
What the finished NCT02351466 record still lists
NCT02351466 is an observational study that tracks outcomes without assigning an intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.
NCT02351466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02351466 about?
NCT02351466 is a clinical study titled "Type 1 Diabetes and the Brain in Children". 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...
What is the current status of trial NCT02351466?
This trial is currently completed. The enrollment target is 221 participants. The study started on 2015-03. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02351466?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT02351466?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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