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NCT03335878 · ClinicalTrials.gov registry record
Brain Health and Development With T1DM
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 290
- Enrollment target
NCT03335878: Completed study, sponsored by Washington University School of Medicine.
NCT03335878 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 290 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03335878 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 290 participants
- Enrollment target
Study Summary
Type 1 diabetes mellitus (T1DM) is typically diagnosed in childhood and over time can lead to complications affecting the retina, heart, kidneys, peripheral nerves, and more recently appreciated, the brain. Studies consistently find that early age of onset and, to a more variable extent, poor glycemic control over years are associated with reduced cognitive performance and altered brain structure in children with T1DM. As yet, the investigators' understanding of why early age of onset would pose more risks for the brain is limited, making interventions difficult to develop. Given that the initial clinical presentation of T1DM in children is the earliest and often the most severe glycemic state experienced over the lifetime, it is possible that age of onset and severity of initial clinical presentation interact to modify risks for brain health and development. This hypothesis has clear clinical implications and the potential to resolve conflicting literature, yet has not been explicitly tested. Thus, the goal of this study is to determine how clinical features at the time of T1DM diagnosis, such as hyperglycemia, diabetic ketoacidosis (DKA) and degree of beta cell failure, interact with age of onset to shape the development of the brain and its responses to subsequent glycemic control.
Primary Outcome
The investigators hypothesize that age of onset and severity of presentation will interact to explain neuroimaging and cognitive outcomes at 3 months post-diagnosis. Specifically, the study investigators predict that patients with earlier age of onset and greater severity of clinical presentation (presence of DKA, greater HbA1c values at diagnosis) will have lower performance and more atypical brain structure and functional connectivity compared to older patients with less severe presentation an
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2021-12-06 |
What the finished NCT03335878 record still lists
NCT03335878 is an observational study that tracks outcomes without assigning an intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03335878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03335878 about?
NCT03335878 is a clinical study titled "Brain Health and Development With T1DM". Type 1 diabetes mellitus (T1DM) is typically diagnosed in childhood and over time can lead to complications affecting the retina, heart, kidneys, peripheral nerves, and more recently appreciated, the brain. Studies consistently find that early age of onset and, to a more variable extent, poor glycem...
What is the current status of trial NCT03335878?
This trial is currently completed. The enrollment target is 290 participants. The study started on 2016-09-01. Estimated completion is 2021-12-06.
Who is sponsoring clinical trial NCT03335878?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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