NCT05277558

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

Brain Health Across the Metabolic Continuum in Youth at Risk for Type 2 Diabetes (T2D)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 117 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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 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.

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 glucose tolerance (O-NGT), and a group with overweight/obesity and dysglycemia (O-DG). Groups will be comparable in age, sex, race/ethnicity, and socio-economic status (SES). Brain structure and function will be examined in all groups using magnetic resonance imaging (MRI) and cognitive tests at study entry (time 1/baseline), and after 21 months (time 2), focusing on a limited number of key outcome variables known to be consistently impaired in obesity or T2D. Targeted MRI measures will be regional volumes (e.g. hippocampus), neuroinflammation via restricted ratio from diffusion basis spectrum imaging (DBSI); hippocampus and white matter tracts), whole-brain cerebral blood flow via arterial spin labeling (ASL). Targeted cognitive measures will be delayed memory, processing speed, and executive function. The ultimate goal of this study is to determine how metabolic factors during neurodevelopment set the stage for the potentially profound, long-term impact of T2D on the brain and its functions. Given that the disease occurs at a time when brains are undergoing dramatic developmental processes, the aggressive nature of youth-onset T2D progression and complications in other organ systems, these results may provide guidance and justification for longer follow-up, interventional and/or mechanistic studies, and have important clinical implications.

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

Interventions

Type	Name	Description
OTHER	Observational	Investigators are observing brain health over time (21 months) in these groups

Timeline

• Start date: 2022-05-24
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2022-03-14
• Last updated: 2025-12-18

Locations

2 sites across 1 country: United States