Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Washington University School of Medicine · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05277558
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–17 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 117
- US sites recruiting
- 2
- Study start
- May 24, 2022
- Record last updated
- December 18, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Observational
Conditions: Type2 Diabetes; Type 2 Diabetes Mellitus in Obese; Dysglycemia; Microvascular Complications; Brain Structure; Obesity, Childhood; Diabetes in Adolescence; Inflammation; Insulin Resistance; Overweight, Childhood; Cognitive Decline
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
Washington University School of Medicine
St Louis, MO 63110
Site contact: Samantha Ranck, MSW, MA · 314-362-6514 · blankens@wustl.edu
UPMC Children's Hospital of Pittsburgh
Pittsburgh, PA 15224
Site contact: Angela Akar, BS, CCRC · 412-692-5928 · angela.akar@chp.edu
Study contacts (from the official record)
- Mary Borgschulte, RN, BSN, CDE · 314-952-8195 · Mary.b@wustl.edu
- Kaeli Spight · 314-362-4721 · kspight@wustl.edu
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