Actively Recruiting
Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Led by Washington University School of Medicine · Updated on 2025-12-18
117
Participants Needed
2
Research Sites
283 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-17 years at first visit, 12-19 years at second visit
- Tanner stage II or above, confirmed by pediatric endocrinologist or trained nurse practitioner
- Otherwise healthy except for obesity
- Weight less than 450 lbs due to MRI scanner limits
- Able and willing to lie flat in MRI scanner and complete cognitive testing
- Fluent in English
You will not qualify if you...
- Syndromic obesity
- History of bariatric surgery
- Insulin treatment for type 2 diabetes (metformin allowed if less than 6 months)
- Contraindications for MRI such as metal implants or claustrophobia
- Presence of braces
- Pregnant or breastfeeding (pregnancy test done for post-menarchal girls)
- Inability to participate in cognitive testing due to sensory or language issues
- Intellectual disability or special education
- Pharmacologic treatment for ADHD
- Prematurity less than 36 weeks gestation
- Complications at birth
- Neurologic co-morbidities like seizures, stroke, or head injury with more than 10 minutes loss of consciousness
- Significant psychiatric disorders such as schizophrenia, bipolar disorder, or current major depression
- Taking psychoactive medications that interfere with testing
- Illegal drug use reported
- Smoking and alcohol use assessed but may not be reliable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
2
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
M
Mary Borgschulte, RN, BSN, CDE
CONTACT
K
Kaeli Spight
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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