Investigating brain health in youth at risk for type 2 diabetes
Brain Health Across the Metabolic Continuum in Youth at Risk for Type 2 Diabetes (T2D)
This study is trying to see how being overweight or having blood sugar issues affects brain health in kids aged 12-17 who might be at risk for type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 117 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 2 sites (St Louis, Missouri and 1 other locations) |
| Trial ID | NCT05277558 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between body mass index (BMI), dysglycemia, and brain health in youth aged 12-17. It involves three groups: those with normal weight and glucose tolerance, those with overweight/obesity and normal glucose tolerance, and those with overweight/obesity and dysglycemia. Using MRI and cognitive tests, researchers will assess brain structure and function at baseline and after 21 months to understand how metabolic factors during development impact brain health. The goal is to identify key factors that may influence the risk of type 2 diabetes and its effects on the brain.
Who should consider this trial
Good fit: Ideal candidates are healthy youth aged 12-17 with varying body weights and glucose tolerance levels.
Not a fit: Patients with syndromic obesity, a history of bariatric surgery, or significant neurological co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how obesity and metabolic factors affect brain development and function in youth, potentially guiding early interventions.
How similar studies have performed: Other studies have explored the relationship between obesity and brain health, but this specific approach focusing on youth and metabolic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
St Louis, Missouri and 1 other locations
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Tamara A Hershey, PhD — Washington University School of Medicine
- Study coordinator: Mary Borgschulte, RN, BSN, CDE
- Email: Mary.b@wustl.edu
- Phone: 314-952-8195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.