[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03899883":3,"trial-entities:NCT03899883":108,"trial-summary:NCT03899883":112},{"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":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":67,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":92,"locations":94,"central_contacts":104,"overall_officials":105,"references":106,"see_also_links":107},"NCT03899883","18-1700","Uric Acid Lowering Trial in Youth Onset T2D","ULTRA-T2D Study: Uric Acid Lowering Trial in Youth Onset T2D","COMPLETED","2023-04-13","2026-06","2026-07-28","2020-01-01","University of Colorado, Denver","OTHER",false,"Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg\u002Fdl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D.\n\nAccordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed \\\u003C21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.",null,[19,20,21,22,23,24,25,26],"Diabetic Kidney Disease","Hyperuricemia","Diabetes","Diabetes Mellitus, Type 2","Type2 Diabetes","Type 2 Diabetes Mellitus","Diabetic Nephropathies","Diabetes Complications",[],"INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},11,"ACTUAL",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","Pegloticase 8 MG\u002FML [Krystexxa]","One time dosing of pegloticase will be administered. Participants will receive an infusion of pegloticase over two hours in the outpatient clinical and translational research center (CTRC) at Children's Hospital Colorado, and will be monitored after infusion.",[41],"Pegloticase",[43,47,50,53,56,58,61,64],{"measure":44,"description":45,"timeFrame":46},"Systolic Blood Pressure","Systolic blood pressure measured by sphygmomanometer","Baseline and 1 week post treatment",{"measure":48,"description":49,"timeFrame":46},"Diastolic Blood Pressure","Diastolic blood pressure measured by sphygmomanometer",{"measure":51,"description":52,"timeFrame":46},"Mean Arterial Pressure","Mean arterial pressure measured by sphygmomanometer",{"measure":54,"description":55,"timeFrame":46},"Pulse Wave Velocity (PWV)","Measured by Aortic MRI renal MRI (4D Flow)",{"measure":57,"description":55,"timeFrame":46},"Wall Shear Stress (WSS)",{"measure":59,"description":60,"timeFrame":46},"Renal Blood Flow","Measured by 4D Flow renal MRI",{"measure":62,"description":63,"timeFrame":46},"Glomerular Filtration Rate","Measured by Iohexol Clearance in Plasma",{"measure":65,"description":66,"timeFrame":46},"Urine Albumin-creatinine Ratio","Measured by albumin and creatinine concentrations in urine",[68],{"measure":69,"description":70,"timeFrame":46},"Serum Uric Acid (sUA)","Measured by baseline sUA compared to sUA one week later","MALE","18 Years","25 Years",{"inclusion":75,"exclusion":80,"raw_text":91},[76,77,78,79],"Men","Ages 18-25","Youth-onset T2D (diagnosis \\\u003C21 years)","serum uric acid ≥ 5 mg\u002Fdl",[81,82,83,84,85,86,87,88,89,90],"Glucose-6-phosphate (G6P) deficiency","Allergies to seafood or iodine","MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs)","HbA1C ≥ 12%","Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia","Congestive heart failure","History of multiple and\u002For severe allergies or anaphylactic reactions","Uric acid lowering medications (ie: allopurinol, febuxostat)","Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol","Participation in another investigational study within 2 weeks prior to study","Inclusion Criteria:\n\n* Men\n* Ages 18-25\n* Youth-onset T2D (diagnosis \\\u003C21 years)\n* serum uric acid ≥ 5 mg\u002Fdl\n\nExclusion Criteria:\n\n* Glucose-6-phosphate (G6P) deficiency\n* Allergies to seafood or iodine\n* MRI contraindications (severe claustrophobia, non-MRI compatible implantable devices, weight ≥ 450 lbs)\n* HbA1C ≥ 12%\n* Recent (1 month prior) diagnosis of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemia\n* Congestive heart failure\n* History of multiple and\u002For severe allergies or anaphylactic reactions\n* Uric acid lowering medications (ie: allopurinol, febuxostat)\n* Pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol\n* Participation in another investigational study within 2 weeks prior to study",[93],"ADULT",[95],{"facility":96,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",{"lat":102,"lon":103},39.72943,-104.83192,[],[],[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110,20,24],"Diabetic Nephropathy",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 11 participants.","completed","Uric Acid Lowering Trial in Youth-Onset Type 2 Diabetes","This study is looking at how a medicine called Pegloticase (Krystexxa) affects blood pressure in young men with type 2 diabetes (T2D) that started in their youth. We know that high uric acid levels are common in young men with youth-onset T2D and can be linked to high blood pressure and kidney problems. This study wants to see if lowering uric acid with a single dose of Pegloticase can improve blood pressure. To join, you must be a man between 18 and 25 years old, have youth-onset T2D, and have high uric acid levels (serum uric acid ≥ 5 mg\u002Fdl). The study will measure your blood pressure at the start and one week after treatment to see if it changes. The current status of this study is unclear.","Participants will be followed for at least one week after treatment, with blood pressure measurements taken at baseline and one week post-treatment.",128,"You would receive a single infusion of Pegloticase over two hours in an outpatient clinic and be monitored afterward. Your blood pressure will be measured at the start and one week after treatment.","Not stated in the trial record.",[],"v2"]