RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-24
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05277558

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * 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).

Contacts and Locations

Study Contact

Mary Borgschulte, RN, BSN, CDE
CONTACT
314-952-8195
Mary.b@wustl.edu
Kaeli Spight
CONTACT
314-362-4721
kspight@wustl.edu

Principal Investigator

Tamara A Hershey, PhD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Silva Arslanian, MD
PRINCIPAL_INVESTIGATOR
UPMC Children's Hospital of Pittsburgh

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Tamara A Hershey, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine
  • Silva Arslanian, MD, PRINCIPAL_INVESTIGATOR, UPMC Children's Hospital of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-24
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2022-05-24
Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • 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