Brain Health in Youth at Risk for Type 2 Diabetes

This observational study is looking at brain health in young people (ages 12-17) who are at risk for Type 2 Diabetes (T2D). Researchers are observing how brain structure and function change over 21 months in three groups: those with normal weight, those with overweight/obesity, and those with overweight/obesity and dysglycemia (higher than normal blood sugar). The goal is to understand how factors like obesity and blood sugar levels might affect the brain as it develops. You might be able to join if you are 12-17 years old, can lie flat in an MRI scanner, and are fluent in English. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 117 participants. It is not a drug trial, but rather observes changes over time.
What's involved
You would have two study visits, 21 months apart, which include an MRI scan and cognitive (thinking and memory) tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 21 months, with measurements taken at the beginning and end of this period.

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NCT05277558

Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)

Recruiting
Not specifiedAges 12–17Observational
Washington University School of Medicine
~117 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Observational

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
hippocampal volume
Measured over 21 months - Visit 1 and Visit 2 are 21 months apart
+5 more outcomes measured
Type2 Diabetes
Type 2 Diabetes Mellitus in Obese
Dysglycemia
Microvascular Complications
Brain Structure
Obesity, Childhood
Diabetes in Adolescence
Inflammation
Insulin Resistance
Overweight, Childhood
Cognitive Decline
2 sites across 2 states
Missouri1
Pennsylvania1
  • Tamara A Hershey, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • Silva Arslanian, MD · PRINCIPAL_INVESTIGATOR · UPMC Children's Hospital of Pittsburgh

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Eligibility criteria

Inclusion

12-17 yrs. old at visit 1, 12-19 yrs. old at visit 2, Tanner II or above (determined through an exam by a pediatric endocrinologist or certified nurse practitioner trained in pediatric endocrinology), otherwise healthy except for obesity, \<450 lbs. (due to MRI scanner limits), able and willing to lie flat within the MRI scanner and do cognitive testing, fluent in English.

Exclusion

Syndromic obesity, history of bariatric surgery, insulin treatment (metformin allowed if \< 6 months) for T2D, contraindications for MRI (metal, claustrophobia), braces, pregnant (pregnancy test will be done on post-menarchal girls) or breastfeeding, inability to participate in cognitive testing due to sensory or language issues, intellectual disability, special education, pharmacologic treatment for Attention Deficit Hyperactivity Disorder (ADHD), prematurity (\<36 weeks gestation), complications at birth, neurologic co-morbidities (e.g., seizures, stroke, head injury with \>10 min loss of consciousness), significant psychiatric disorders (e.g., schizophrenia, bipolar disorder, current major depression), taking psychoactive medications (e.g., antipsychotics) that would interfere with testing or reporting illegal drug use. Self-reported smoking and alcohol use and length of time with obesity will be assessed by history (although these measures may not be fully reliable).
  • hippocampal volume21 months - Visit 1 and Visit 2 are 21 months apart

    To determine hippocampal volumes, investigators will use the validated, objective and semi-automatic segmentation program Automated MRI Brain Volumetry System (volBrain). Hippocampal volumes will be obtained for each subject at each visit for primary analyses. Left and right volumes will be averaged, since lateralized findings are not hypothesized.

  • restricted fraction21 months - Visit 1 and Visit 2 are 21 months apart

    Investigators will use Diffusion Basis Spectrum Imaging (DBSI) models on diffusion weighted images (DWI) to assess restricted fraction within the hippocampus and throughout white matter tracts.

  • Whole brain cerebral blood flow21 months - Visit 1 and Visit 2 are 21 months apart

    Pseudo-continuous arterial spin labeling (pCASL) will be used to measure cerebral blood flow (CBF) implemented with an arterial spin labeling (ASL) sequence 228 and volume navigators (vNavs) to minimize motion artifact. Global CBF across pairs of frames will be scaled additively to the median value. Investigators will assess the number of voxels that statistically deviate from a normative value ('distributed deviating voxels') and compared between groups.

  • Declarative Memory21 months - Visit 1 and Visit 2 are 21 months apart

    Investigators will use the total score from the Paired Associates Memory Test, an experimental cognitive task measuring delayed declarative memory

  • Processing speed21 months - Visit 1 and Visit 2 are 21 months apart

    Investigators will use the raw scores from the NIH Toolbox Pattern Comparison Processing Speed task.

  • Executive Function21 months - Visit 1 and Visit 2 are 21 months apart

    Investigators will use an average of the (z scores) from the NIH Toolbox Flanker Inhibitory Control \& Attention, Dimensional Change Card Sort and List Sorting tasks.