Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 11, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how being overweight or having obesity affects the brains of young people who are at risk for type 2 diabetes (T2D). Researchers want to understand how factors like insulin resistance (when your body has trouble using insulin), inflammation, and changes in blood sugar levels might influence brain structure and function. By studying these relationships, they hope to learn more about the risks for cognitive decline, or thinking difficulties, in youth with different body weights.

To participate in this study, you need to be between 12 and 19 years old and generally healthy, except for having obesity. Some important things to note: you should not have certain medical conditions or treatments that could interfere with the study, like a history of severe obesity syndromes or neurological issues. If you join the trial, you'll undergo tests that include lying in an MRI machine to take pictures of your brain and some cognitive tests to assess your thinking skills. This study is currently recruiting participants, so if you or someone you know fits the criteria, it could be a valuable opportunity to contribute to understanding brain health in young people at risk for diabetes.

Gender

ALL

Eligibility 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).