[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460586":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":34,"locations":44,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":116,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal Weight-Normal Glucose Tolerant (NW-NGT)",null,"(1) a group that is the normal weight (BMI\\\u003C85th%) and has normal glucose tolerance (NW-NGT)",[13],"Other: Observational",{"label":15,"type":10,"description":16,"interventionNames":17},"Overweight and\u002For obese and has normal glucose tolerance (O-NGT)","(2) a group that is overweight and\u002For obese (BMI \\>85th%) and has normal glucose tolerance (O-NGT)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Overweight and\u002For Obese and has dysglycemia (O-DG)","(3) group that is overweight and\u002For obese (BMI \\>85th%) and has dysglycemia (O-DG; fasting plasma glucose ≥100 mg\u002Fdl and\u002For 2-hour glucose ≥140 mg\u002Fdl oral glucose tolerance test (OGTT) and laboratory-based HbA1c ≥5.8 and ≤8.0%, if treatment naïve).",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Observational","Investigators are observing brain health over time (21 months) in these groups",[9,19,15],[28,31],{"name":29,"affiliation":5,"role":30},"Tamara A Hershey, PhD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Silva Arslanian, MD","UPMC Children's Hospital of Pittsburgh",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Mary Borgschulte, RN, BSN, CDE","CONTACT","314-952-8195","Mary.b@wustl.edu",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Kaeli Spight","314-362-4721","kspight@wustl.edu",[45,66],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.19789,38.62727,{"lat":56,"lon":55},[59,63,64],{"name":60,"role":37,"phone":61,"phoneExt":10,"email":62},"Samantha Ranck, MSW, MA","314-362-6514","blankens@wustl.edu",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},{"name":65,"role":30,"phone":10,"phoneExt":10,"email":10},"Tamara G Hershey, PhD",{"facility":33,"status":46,"city":67,"state":68,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Pittsburgh","Pennsylvania","15224",{"type":53,"coordinates":71},[72,73],-79.99589,40.44062,{"lat":73,"lon":72},[76,80],{"name":77,"role":37,"phone":78,"phoneExt":10,"email":79},"Angela Akar, BS, CCRC","412-692-5928","angela.akar@chp.edu",{"name":32,"role":30,"phone":10,"phoneExt":10,"email":10},{"type":82,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[84],{"name":85,"class":86},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100460586","brain-health-in-youth-with-normal-weight-overweight-and-obesity-at-risk-for-type-2-diabetes-t2d-100460586",false,"NCT05277558","Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)","Brain Health Across the Metabolic Continuum in Youth at Risk for Type 2 Diabetes (T2D)","Metabrain","Inclusion Criteria:\n\n* 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, \\\u003C450 lbs. (due to MRI scanner limits), able and willing to lie flat within the MRI scanner and do cognitive testing, fluent in English.\n\nExclusion Criteria:\n\n* Syndromic obesity, history of bariatric surgery, insulin treatment (metformin allowed if \\\u003C 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 (\\\u003C36 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).",true,"ALL","12 Years","17 Years",{"count":100,"type":101},117,"ESTIMATED","OBSERVATIONAL","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.",[105,106,107,108,109,110,111,112,113,114,115],"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",[117],"Brain, Health, Youth, Type 2 Diabetes Mellitus, overweight, obesity","2025-12-16",{"date":120,"type":121},"2025-12-18","ACTUAL",{"date":123,"type":121},"2022-05-24",{"date":125,"type":101},"2027-10-31",{"name":5,"class":6},2]