Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Metabrain
Brain Health Across the Metabolic Continuum in Youth at Risk for Type 2 Diabetes (T2D)
2 other identifiers
observational
117
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
December 18, 2025
December 1, 2025
4.4 years
February 11, 2022
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
hippocampal volume
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.
21 months - Visit 1 and Visit 2 are 21 months apart
restricted fraction
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.
21 months - Visit 1 and Visit 2 are 21 months apart
Whole brain cerebral blood flow
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.
21 months - Visit 1 and Visit 2 are 21 months apart
Declarative Memory
Investigators will use the total score from the Paired Associates Memory Test, an experimental cognitive task measuring delayed declarative memory
21 months - Visit 1 and Visit 2 are 21 months apart
Processing speed
Investigators will use the raw scores from the NIH Toolbox Pattern Comparison Processing Speed task.
21 months - Visit 1 and Visit 2 are 21 months apart
Executive Function
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.
21 months - Visit 1 and Visit 2 are 21 months apart
Study Arms (3)
Normal Weight-Normal Glucose Tolerant (NW-NGT)
(1) a group that is the normal weight (BMI\<85th%) and has normal glucose tolerance (NW-NGT)
Overweight and/or obese and has normal glucose tolerance (O-NGT)
(2) a group that is overweight and/or obese (BMI \>85th%) and has normal glucose tolerance (O-NGT)
Overweight and/or Obese and has dysglycemia (O-DG)
(3) group that is overweight and/or obese (BMI \>85th%) and has dysglycemia (O-DG; fasting plasma glucose ≥100 mg/dl and/or 2-hour glucose ≥140 mg/dl oral glucose tolerance test (OGTT) and laboratory-based HbA1c ≥5.8 and ≤8.0%, if treatment naïve).
Interventions
Investigators are observing brain health over time (21 months) in these groups
Eligibility Criteria
Pubertal youth ages 12-17 yrs. will be enrolled in a longitudinal design. Investigators chose to focus on the ages where there is the highest prevalence of impaired glucose tolerance (IGT) and T2D, reducing variability in neurodevelopmental and Tanner stages in the three cohorts. Investigators will follow participants for 21 months to ensure that enough time has passed to see changes in the stated outcome measures.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Biospecimen
See page 12 of the protocol.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara A Hershey, PhD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Silva Arslanian, MD
UPMC Children's Hospital of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
March 14, 2022
Study Start
May 24, 2022
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- within 12 months of end of data collection, data entry, quality control and image processing
- Access Criteria
- PI will need to request data for legitimate scientific purpose.
Investigators affirm that data and research resources will be shared. Any shared data will have low re-identification potential. The Research Design \& Biostatistics Group of the investigative team's Washington University's Clinical Translational Science Award (CTSA) provides access to the REDCap database to facilitate secure data sharing with approved investigators within the University as well as with approved collaborators. De-identified MRI scans will be shared with approved investigators through the Central Neuroimaging Data Archive (CNDA), an online, secure image archive system.