Actively Recruiting
Brain Health Across the Metabolic Spectrum in Youth 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
52 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
Researchers are studying youth aged 12 to 17 years across different body weight and blood sugar levels to understand how features related to type 2 diabetes risk, such as obesity and insulin resistance, affect brain structure and function. The study aims to find which factors are most linked to changes in the brain over time and how these differ from normal brain development during puberty. This research focuses on youth given the aggressive progression of type 2 diabetes and its possible long-term impact on brain health. The study observes three groups of pubertal youth: normal weight with normal glucose tolerance, overweight or obese with normal glucose tolerance, and overweight or obese with dysglycemia. Brain health is assessed using magnetic resonance imaging (MRI) scans and cognitive tests at the start and again after 21 months. Key brain measures include hippocampal volume, neuroinflammation, cerebral blood flow, and cognitive skills such as memory, processing speed, and executive function. Participants will have two visits 21 months apart, during which MRI scans and cognitive tests will be performed. Researchers will track changes in brain structure and function over this period and relate these to metabolic factors like obesity and blood sugar levels. The study will also collect information on insulin resistance, inflammation, and other diabetes-related factors to understand their effects on the developing brain. The overall participation period spans 21 months with detailed brain and cognitive assessments.
CONDITIONS
Brief 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...
- Participants aged 12 to 17 years at the first visit, and up to 19 years at the second visit
- Tanner stage II or above confirmed by a pediatric endocrinologist or trained nurse practitioner
- Otherwise healthy except for obesity
- Weight less than 450 pounds (due to MRI scanner limits)
- Able and willing to lie flat during MRI scans and complete cognitive testing
- Fluent in English
You will not qualify if you...
- Syndromic obesity or 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
- Wearing braces
- Pregnant or breastfeeding (pregnancy test for post-menarchal girls)
- Unable to participate in cognitive testing due to sensory or language issues
- Intellectual disability or special education
- Taking medication for ADHD
- Premature birth (less than 36 weeks gestation) or complications at birth
- Neurologic conditions like seizures, stroke, or significant head injury
- Significant psychiatric disorders such as schizophrenia, bipolar disorder, or major depression
- Taking psychoactive medications that interfere with testing or report of illegal drug use
- Self-reported smoking and alcohol use will be assessed but may not exclude participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo brain MRI scans and cognitive testing to assess brain structure and function at the start of the study.
1 baseline visit (in-person)
Duration - 21 months
Participants are observed over 21 months to study brain health across different metabolic groups without receiving active treatment.
2 visits (baseline and 21 months follow-up, both in-person)
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
K
Kaeli Spight
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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