MetabrainBrain Structure and Function in Youth at Risk for Type 2 Diabetes
This observational study aims to understand the brain structure and function in youth at risk for Type 2 Diabetes, focusing on aspects such as declarative memory, executive function, hippocampal volume, processing speed, restricted fraction in the hippocampus and white matter tracts, and whole brain cerebral blood flow.
Data Collection
Collected from today forward - ProspectiveMental Disorders+19
+ Body Weight
+ Cognition Disorders
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: May 24, 2022
Actual date on which the first participant was enrolled.This study focuses on brain health in youth at risk for Type 2 Diabetes (T2D). It involves three groups of adolescents aged 12-17 years: those with normal weight and glucose tolerance, those with overweight/obesity but normal glucose tolerance, and those with overweight/obesity and dysglycemia. The study aims to understand how metabolic factors during brain development might impact the brain and its functions in the long term, especially in relation to T2D. This research is crucial as T2D often occurs during significant brain development stages, and youth-onset T2D can progress aggressively, leading to complications in various organ systems. During the study, brain structure and function will be examined in all groups using magnetic resonance imaging (MRI) and cognitive tests at the start and after 21 months. The study will measure specific aspects like regional brain volumes, neuroinflammation, cerebral blood flow, delayed memory, processing speed, and executive function. These measurements will help determine any potential impacts of T2D on the brain. The results could provide valuable guidance for future studies and have significant clinical implications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.117 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Washington University School of Medicine
St Louis, United StatesOpen Washington University School of Medicine in Google MapsUPMC Children's Hospital of Pittsburgh
Pittsburgh, United States