[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05008276":3,"trial-entities:NCT05008276":138,"trial-summary:NCT05008276":144},{"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":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":56,"secondary_outcomes":65,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":96,"locations":98,"central_contacts":130,"overall_officials":133,"references":136,"see_also_links":137},"NCT05008276","21-3019","Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)","PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress","RECRUITING","2027-12-01","2025-03","2025-03-24","2021-09-27","Petter Bjornstad","OTHER",false,"Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.","Puberty is a complex process of physiological changes, including neuroreproductive and growth hormone activation and rapid organ growth, that may predispose organs to injury. The kidneys may be especially susceptible because they are highly metabolically active and second only to the heart with respect to oxygen consumption per tissue mass. During puberty, the kidneys almost double in size, likely increasing the kidneys' already high energy expenditure. In parallel, puberty is associated with physiologic insulin resistance (IR), which is accentuated in obesity. Our central hypothesis is that obese youth with prediabetes and T2D experience relative kidney hypoxia during puberty due to a metabolic mismatch between increased energy expenditure and impaired substrate metabolism. In turn, the kidney hypoxia results in loss of glomerular charge and size selectivity leading to increased transglomerular transport of protein and kidney dysfunction. Our preliminary data showed that pubertal adolescents with obesity and\u002For diabetes exhibit relative kidney hypoxia compared to normal weight controls using functional magnetic resonance imaging (MRI) and that relative kidney hypoxia is greater in late vs. early puberty. However, determining the pubertal mechanisms contributing to kidney injury in youth with obesity and T2D requires serial evaluations throughout puberty. To assess the impact of pubertal changes within a 5-year study period, the investigators propose an accelerated longitudinal study design in which the investigators will enroll adolescents (8-14 years, 50% girls) with obesity and\u002For elevated hemoglobin A1c (HbA1c ≥6%) \\[n=60\\], and healthy normoglycemic controls \\[n=40\\] at Tanner (pubertal) stages 1-4 and examine them at baseline, 1 and 2-years. The investigators will then compare data by Tanner stage to construct an integrated portrayal of the physiological changes that occur throughout puberty. Given the rarity of T2D prior to pubertal onset, the investigators chose to enroll a high high-risk group: youth with obesity and\u002For HbA1c ≥6.0% to represent youth ranging from those at magnified risk of developing T2D to those recently diagnosed.",[19,20,21,22,23,24],"Type 2 Diabetes Mellitus","Diabetic Kidney Disease","Adolescent Obesity","Pre Diabetes","Kidney Hypoxia","Puberty",[],"OBSERVATIONAL",null,[],{"count":30,"type":31},100,"ESTIMATED",[33,44,50],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DRUG","Aminohippurate Sodium Inj 20%","Diagnostic aid\u002Fagent used to measure effective renal plasma flow (ERPF)",[38,39],"Healthy normal-weight controls","Youth with overweight\u002Fobesity and\u002For newly diagnosed T2D and elevated HbA1c",[41,42,43],"Sodium 4-amino hippurate (PAH) inj 20% 2g\u002F10mL","Para-aminohippurate","Aminohippuric acid",{"type":34,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Iohexol Inj 300 MG\u002FML","Diagnostic aid\u002Fagent used to measure glomerular filtration rate (GFR)",[38,39],[49],"omnipaque 300",{"type":34,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Dextran 40","Diagnostic aid\u002Fagent used to measure glomerular size and selectivity",[38,39],[55],"Dextran Sieving",[57,61],{"measure":58,"description":59,"timeFrame":60},"Effective renal plasma flow (ERPF)","Measured by PAH Clearance","3 Hours",{"measure":62,"description":63,"timeFrame":64},"Glomerular Filtration Rate (GFR)","Measured by iohexol clearance","3 hours",[66,69,73],{"measure":67,"description":68,"timeFrame":64},"Insulin Sensitivity","Measured by IV glucose tolerance test (IVGTT)",{"measure":70,"description":71,"timeFrame":72},"Renal perfusion","Arterial spin labeling (ASL) MRI","10 min",{"measure":74,"description":75,"timeFrame":76},"Renal oxygenation","Blood oxygen level dependent (BOLD) MRI","60 min","ALL","8 Years","14 Years",true,{"inclusion":82,"exclusion":87,"raw_text":95},[83,84,85,86],"HbA1c ≥6.0% for untreated high-risk group","BMI ≥ 85th %ile for high-risk group","Normal HbA1c ≤5.6% for control group","Type 1 diabetes (T1D) Antibody negative",[88,89,90,91,92,93,94],"History of Chronic kidney disease (CKD) or acute kidney injury (AKI)","Metabolic disorder prohibiting safe fasting","Iodine or penicillin allergy","Pregnancy","Thrombophilia","MRI contraindications","Hormone therapy","Inclusion Criteria:\n\n* HbA1c ≥6.0% for untreated high-risk group\n* BMI ≥ 85th %ile for high-risk group\n* Normal HbA1c ≤5.6% for control group\n* Type 1 diabetes (T1D) Antibody negative\n\nExclusion Criteria:\n\n* History of Chronic kidney disease (CKD) or acute kidney injury (AKI)\n* Metabolic disorder prohibiting safe fasting\n* Iodine or penicillin allergy\n* Pregnancy\n* Thrombophilia\n* MRI contraindications\n* Hormone therapy",[97],"CHILD",[99,116],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":113},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",[106,111],{"name":107,"role":108,"phone":109,"email":110},"Megan Kelsey, MD, MS","CONTACT","720-777-0991","Megan.Kelsey@childrenscolorado.org",{"name":107,"role":112},"PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},39.72943,-104.83192,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":104,"contacts":121,"geoPoint":127},"Seattle Children's Hospital","Seattle","Washington","98102",[122,126],{"name":123,"role":108,"phone":124,"email":125},"Petter M Bjornstad, MD","(206) 616 3543","pettermb@uw.edu",{"name":123,"role":112},{"lat":128,"lon":129},47.60621,-122.33207,[131],{"name":132,"role":108,"phone":124,"email":125},"Petter Bjornstad, MD",[134],{"name":132,"affiliation":135,"role":112},"University of Washington - Medicine Diabetes Institute",[],[],{"nct_id":4,"conditions":139,"biomarkers":143},[140,141,142,19],"Diabetic Nephropathy","Obesity","Prediabetes",[],{"nct_id":4,"found":80,"summary":145,"prompt_version":155},{"design":146,"status":147,"heading":148,"summary":149,"follow_up":150,"word_count":151,"commitments":152,"compensation":153,"drugs_mentioned":154},"This is an observational study, meaning researchers will observe participants without assigning specific treatments. It plans to enroll 100 participants.","completed","Understanding Kidney Health in Youth with Diabetes and Obesity (PANTHER Study)","This observational study, called the PANTHER Study, is looking at how puberty affects kidney health in young people (ages 8-14) who have type 2 diabetes, pre-diabetes, or obesity. Researchers want to understand why kidney disease often starts early in life for these young people. You might be able to join if you have certain levels of HbA1c (a measure of blood sugar) or BMI (Body Mass Index), and do not have type 1 diabetes or existing kidney disease. The study uses diagnostic agents like Aminohippurate Sodium Inj 20%, Iohexol Inj 300 MG\u002FML, and Dextran 40 to measure how well your kidneys are working, specifically your effective renal plasma flow (ERPF) and glomerular filtration rate (GFR) over 3 hours. The study aims to enroll 100 participants.","The primary measurements for kidney function (ERPF and GFR) are taken at 3 hours.",125,"Not specified in the trial record.","Not stated in the trial record.",[35,45,51],"v2"]