Investigating brain health in youth at risk for type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.