TrialGlobe

Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05277558

Recruiting nowNot applicableObservational

What this study is about

Investigators propose to study youth across the spectrum of body mass index (BMI) and dysglycemia. This approach will allow investigators to disentangle the relationship of key features of type 2 diabetes (T2D) risk (e.g. obesity) with intermediary physiologic changes (e.g. insulin resistance, inflammation, β-cell dysfunction and dysglycemia) that pose a risk for the brain. Investigators will determine which of these factors are most associated with differences in brain structure and function among groups, over time, and how these effects differ from normal neurodevelopment.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years
SexAll
Healthy volunteersAccepted
ConditionType2 Diabetes, Type 2 Diabetes Mellitus in Obese, Dysglycemia, Microvascular Complications, Brain Structure, Obesity, Childhood, Diabetes in Adolescence, Inflammation, Insulin Resistance, Overweight, Childhood, Cognitive Decline

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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).

Treatments and study arms

Observational

Other

Investigators are observing brain health over time (21 months) in these groups

Primary outcomes

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

UPMC Children's Hospital of Pittsburgh🇺🇸 Pittsburgh, Pennsylvania, United States
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Angela Akar, BS, CCRCContact
Email · Call 412-692-5928
Silva Arslanian, MDPrincipal Investigator
Washington University School of Medicine🇺🇸 St Louis, Missouri, United States
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Samantha Ranck, MSW, MAContact
Email · Call 314-362-6514
Kaeli SpightContact
Email · Call 314-362-4721
Tamara G Hershey, PhDPrincipal Investigator