MedTrace Logo

Type 1 Diabetes and the Brain in Children

NCT02351466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2020-10-22

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

OTHER

Observational

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic

  • Allan L Reiss, MD · Stanford University

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-11-30
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351466 on ClinicalTrials.gov