[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05530356":3,"trial-entities:NCT05530356":161,"trial-summary:NCT05530356":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":17,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":72,"secondary_outcomes":112,"sex":126,"minimum_age":127,"maximum_age":128,"healthy_volunteers":17,"eligibility_criteria":129,"std_ages":141,"locations":144,"central_contacts":154,"overall_officials":155,"references":159,"see_also_links":160},"NCT05530356","20-2961","Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study","Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes: A Follow-up Study","ENROLLING_BY_INVITATION","2029-05","2022-10","2022-11-02","2022-09-30","University of Colorado, Denver","OTHER",false,"The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) \\[COMIRB #16-1752\\] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and\u002For obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.",null,[19,20,21,22,23,24,25],"Type 2 Diabetes","Diabetes Type 2","Diabetic Nephropathies","Nephropathy","Obesity","Adolescent Obesity","Diabetic Kidney Disease",[],"OBSERVATIONAL",[],{"count":30,"type":31},100,"ESTIMATED",[33,45,51,58,65],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":41},"DRUG","Aminohippurate Sodium Inj 20%","Diagnostic aid\u002Fagent used to measure effective renal plasma flow (ERPF)",[38,39,40],"Lean Controls (previously enrolled in the Renal HEIR Study)","Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)","Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)",[42,43,44],"Sodium 4-amino hippurate (PAH) inj 20% 2g\u002F10mL","Para-aminohippurate","Aminohippuric acid",{"type":34,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Iohexol Inj 300 MG\u002FML","Diagnostic aid\u002Fagent used to measure glomerular filtration rate (GFR)",[38,39,40],[50],"omnipaque 300",{"type":34,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Dextran 40","Diagnostic aid\u002Fagent used to measure glomerular size selectivity",[38,39,40],[56,57],"Dextran","LMD",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"PROCEDURE","Renal Biopsy","Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.",[39],[64],"Kidney Biopsy",{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"RADIATION","Positron Emission Tomography","Imaging study performed to study renal oxidative metabolism",[39,40],[71],"PET Scan",[73,77,80,84,88,91,95,97,99,102,104,106,108,110],{"measure":74,"description":75,"timeFrame":76},"Effective Renal Plasma Flow (ERPF)","Measured by PAH clearance","4 Hours",{"measure":78,"description":79,"timeFrame":76},"Glomerular Filtration Rate","Measured by Iohexol Clearance",{"measure":81,"description":82,"timeFrame":83},"Glomerular Size Selectivity","Measured by Dextran sieving","4 hours",{"measure":85,"description":86,"timeFrame":87},"Renal Oxygen Availability","Measured by functional kidney MRI","1 hour",{"measure":89,"description":90,"timeFrame":87},"Renal Perfusion","Measured by functional kidney MRI + PET Scan",{"measure":92,"description":93,"timeFrame":94},"11-C Acetate Tracer Uptake","Measured by PET Scan","1 Hour",{"measure":96,"description":93,"timeFrame":94},"Renal Oxidative Metabolism",{"measure":98,"description":93,"timeFrame":94},"Blood Volume Fraction",{"measure":100,"description":101,"timeFrame":94},"Glomerular Basement Membrane Width","Measured by Renal Biopsy",{"measure":103,"description":101,"timeFrame":94},"Mesangial Expansion",{"measure":105,"description":101,"timeFrame":94},"Interstitial Fibrosis",{"measure":107,"description":101,"timeFrame":94},"Renal Arteriosclerosis",{"measure":109,"description":101,"timeFrame":94},"Spatial Transcriptomics",{"measure":111,"description":101,"timeFrame":94},"Spatial Metabolomics",[113,117,120,122,124],{"measure":114,"description":115,"timeFrame":116},"Pulse Wave Velocity between Carotid and Femoral Artery","Measured by PWV","10 minutes",{"measure":118,"description":119,"timeFrame":94},"Whole brain gray matter volume","Measured by brain MRI",{"measure":121,"description":119,"timeFrame":94},"Whole brain cortical thickness",{"measure":123,"description":119,"timeFrame":94},"Whole brain resting-state network connectivity",{"measure":125,"description":119,"timeFrame":94},"Age-corrected composite fluid cognition score","ALL","12 Years","26 Years",{"inclusion":130,"exclusion":133,"raw_text":140},[131,132],"Obese youth with and without Type 2 Diabetes + lean controls who were previously enrolled in the Renal HEIR Study","Participants who will undergo a PET Scan: ≥ 18 years",[134,135,136,137,138,139],"Anemia","Seafood, iodine, or penicillin allergy","Pregnancy","MRI Scanning contraindications (claustrophobia, implantable devices, \\>550 lbs)","History of bleeding or clotting disorders, thrombocytopenia, warfarin and\u002For heparin use","Taking sulfonamides, procaine, thiazolsulfone or probenecid","Inclusion Criteria:\n\n* Obese youth with and without Type 2 Diabetes + lean controls who were previously enrolled in the Renal HEIR Study\n* Participants who will undergo a PET Scan: ≥ 18 years\n\nExclusion Criteria:\n\n* Anemia\n* Seafood, iodine, or penicillin allergy\n* Pregnancy\n* MRI Scanning contraindications (claustrophobia, implantable devices, \\>550 lbs)\n* History of bleeding or clotting disorders, thrombocytopenia, warfarin and\u002For heparin use\n* Taking sulfonamides, procaine, thiazolsulfone or probenecid",[142,143],"CHILD","ADULT",[145],{"facility":146,"city":147,"state":148,"zip":149,"country":150,"geoPoint":151},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",{"lat":152,"lon":153},39.72943,-104.83192,[],[156],{"name":157,"affiliation":146,"role":158},"Petter Bjornstad, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":162,"biomarkers":164},[23,163],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]