Last reviewed · How we verify
NCT03335878: NewT
Brain Health and Development With T1DM
trial in T1DM in 290 participants. Completed in 6 December 2021.
6 December 2021
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 290 |
| Start date | 1 September 2016 |
| Primary completion | 6 December 2021 |
| Estimated completion | 6 December 2021 |
| Sites | 1 location across United States |
Conditions studied
- T1DM — all drugs for T1DM →
- Brain Development — all drugs for Brain Development →
Sponsor
Washington University School of Medicine
Who can join
Adults 4 to 16, any sex, with T1DM or Brain Development. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Neurofilament light chain but not glial fibrillary acidic protein serum levels are elevated in Wolfram syndrome.
Jansen MJ, Lugar HM, Brown CM, Tang AF, et al · · 2026 · PMID 41929703 · DOI 10.3389/fnins.2026.1805916
Verify or expand the search:
- PubMed search for NCT03335878
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for T1DM
Currently open trials in the same condition.
- NCT06575426 — A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes M · Phase 1, PHASE2 · recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
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- NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
- NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
- NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03335878 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 11 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03335878.
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