Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04135365 · ClinicalTrials.gov registry record
Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 12
- Enrollment target
NCT04135365: Completed study, sponsored by Vanderbilt University Medical Center.
NCT04135365 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04135365 has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study 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 sleep quality, caregiver distress, and use of diabetes devices). In addition, the study will optimize imaging protocols and processing tools to allow for harmonization of neuroimaging data across sites and scanners for the most robust analysis.
Primary Outcome
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.
Interventions
- BEHAVIORAL neurocognitive assessment
- BEHAVIORAL neuroimaging assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2022-10-31 |
What the finished NCT04135365 record still lists
NCT04135365 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which neurocognitive assessment is the first listed.
NCT04135365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04135365 about?
NCT04135365 is a clinical study titled "Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study". 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 sleep quality, caregiver distress, and use of diabetes devices). In addition, the study will optimi...
What is the current status of trial NCT04135365?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2021-01-18. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT04135365?
The interventions under investigation include: neurocognitive assessment (BEHAVIORAL), neuroimaging assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT04135365?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI