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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: t
View:

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Pennsylvania
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Mary Borgschulte, RN, BSN, CDE
Mary.b@wustl.edu
314-952-8195
Backup
Kaeli Spight
kspight@wustl.edu
314-362-4721
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 117
Treatments
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).
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov