Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT05277558

Conditions

Type2 Diabetes

Type 2 Diabetes Mellitus in Obese

Dysglycemia

Microvascular Complications

Brain Structure

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Observational

Study Details

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 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.

Conditions

Type2 Diabetes

Type 2 Diabetes Mellitus in Obese

Dysglycemia

Microvascular Complications

Brain Structure

Study ID

NCT05277558

Start date

May 24, 2022

Status verified date

Dec, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

117 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal Weight-Normal Glucose Tolerant (NW-NGT)

(1) a group that is the normal weight (BMI<85th%) and has normal glucose tolerance (NW-NGT)

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)

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).

Interventions

Observational

Investigators are observing brain health over time (21 months) in these groups

Primary outcome measure

  • hippocampal volume [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]
  • restricted fraction [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]
  • Whole brain cerebral blood flow [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]
  • Declarative Memory [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]
  • Processing speed [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]
  • Executive Function [ Time Frame: 21 months - Visit 1 and Visit 2 are 21 months apart ]

Central Contacts and Locations

Central contacts

Mary Borgschulte, RN, BSN, CDE

314-952-8195Mary.b@wustl.edu

Kaeli Spight

314-362-4721kspight@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Samantha Ranck, MSW, MA

314-362-6514blankens@wustl.edu

Kaeli Spight

314-362-4721kspight@wustl.edu

Principal Investigator:

Tamara G Hershey, PhD

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Angela Akar, BS, CCRC

412-692-5928angela.akar@chp.edu

Principal Investigator:

Silva Arslanian, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Brain, Health, Youth, Type 2 Diabetes Mellitus, overweight, obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-18.