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Completed

NCT Number: NCT02351466

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 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

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About this study

Study participation will last about 2 to 2 1/12 years and will include a brain MRI without sedation, as well as a functional MRI and neurocognitive testing. The children with T1D will wear a continuous glucose monitor (CGM), will follow up every 3 months and will be asked to wear the CGM each time. The structural and functional MRI and neurocognitive testing will be repeated 2 yrs from baseline.

The healthy controls will also undergo MRI and cognitive testing as well as have a blood sample at baseline and after 2 years.

Parents of newly recruited subjects will also have abbreviated IQ testing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for T1 Diabetes Group:

  • Diabetes diagnosed after age 6 months
  • Gestational age >34 weeks, birth weight >2kg

Inclusion criteria

for Healthy Control Group:

  • Normal HbA1C and fasting blood glucose
  • Negative diabetes auto-antibodies (those that are siblings of T1D patients)
  • Gestational age >34 weeks, birth weight >2kg

Exclusion criteria

for Both Groups:

  • History of mental retardation, language or learning disability
  • Known genetic or medical problem that could impair brain development
  • Abnormality of the brain/nervous system, visual or hearing problem
  • History of seizures not associated with fever
  • Previous inpatient psychiatric treatment
  • Unable to have a MRI of the head due to metal appliances

Treatment and study plan

Observational

Other

Primary outcomes

  1. Changes in total and regional gray and white matter volumes and white matter microstructure.

    Time frame: 2 years

    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 longitudinally between scans with CGM and HbA1c for children with Type 1 Diabetes.

Secondary outcomes

  1. Measures of activation of frontal-parietal networks and functional connectivity of resting state networks using blood oxygen level dependent (BOLD)-functional MRI.

    Time frame: 2 years

  2. Changes in Neurocognitive metrics including IQ as well as executive and visual-spatial memory.

    Time frame: 2 years

    We will perform neurocognitive metrics reflecting frontal, parietal-occipital and hippocampal function. Children with T1D will be followed longitudinally and compared with controls to determine whether these differences are associated with measures of glycemic control.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Stanford University
  • University of Iowa
  • Washington University School of Medicine
  • Yale University

Registry information

Official study title

Type 1 Diabetes and the Brain in Children: Metabolic Interventions. Protocol #1: Longitudinal Assessment

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2015
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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