Status:
RECRUITING
Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type2 Diabetes
Type 2 Diabetes Mellitus in Obese
Eligibility:
All Genders
12-17 years
Brief Summary
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 diab...
Detailed Description
Investigators will study three groups of pubertal youth, ages 12-17 yrs old (n=31 each): a group with normal weight and normal glucose tolerance (NW-NGT), a group with overweight/obesity and normal gl...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT05277558
Start Date
May 24 2022
End Date
October 31 2027
Last Update
December 18 2025
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224