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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05277558
Status
Recruiting
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Conditions

  • Brain Structure
  • Cognitive Decline
  • Diabetes in Adolescence
  • Dysglycemia
  • Inflammation
  • Insulin Resistance
  • Microvascular Complications
  • Obesity, Childhood
  • Overweight, Childhood
  • Type 2 Diabetes Mellitus in Obese
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Observational — OTHER
    Investigators are observing brain health over time (21 months) in these groups

Study Details

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.

Key Dates

Start date
May 24, 2022
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
117 participants (estimated)

Arms

  • Arm: Normal Weight-Normal Glucose Tolerant (NW-NGT)
    (1) a group that is the normal weight (BMI\<85th%) and has normal glucose tolerance (NW-NGT)
  • Arm: Overweight and/or obese and has normal glucose tolerance (O-NGT)
    (2) a group that is overweight and/or obese (BMI \>85th%) and has normal glucose tolerance (O-NGT)
  • Arm: Overweight and/or Obese and has dysglycemia (O-DG)
    (3) group that is overweight and/or obese (BMI \>85th%) and has dysglycemia (O-DG; fasting plasma glucose ≥100 mg/dl and/or 2-hour glucose ≥140 mg/dl oral glucose tolerance test (OGTT) and laboratory-based HbA1c ≥5.8 and ≤8.0%, if treatment naïve).

Primary Outcome Measure

hippocampal volume [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Samantha Ranck, MSW, MA
[email protected]
314-362-6514
Kaeli Spight
[email protected]
314-362-4721
Tamara G Hershey, PhD (PRINCIPAL_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Angela Akar, BS, CCRC
[email protected]
412-692-5928
Silva Arslanian, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MOUPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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