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Clinical Trial Details

Trial ID: L4503
Source ID: NCT03584217
Associated Drug: Aminohippurate Sodium Inj 20%
Title: Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study
Acronym: Renal-HEIR
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Obesity|Nephropathy|Adolescent Obesity
Interventions: DRUG: Aminohippurate Sodium Inj 20%|DRUG: Iohexol Inj 300 MG/ML|PROCEDURE: Renal Biopsy
Outcome Measures: Primary: Effective renal plasma flow (ERPF), Measured by PAH clearance, 4 hours|Glomerular filtration rate (GFR), Measured by iohexol clearance, 4 hours | Secondary: Insulin sensitivity, Measured by hyperinsulinemic-euglycemic clamp, 4 hours|Renal oxygenation, Blood oxygen level dependent (BOLD) MRI, 60 min|Renal perfusion, Arterial spin labeling (ASL) MRI, 10 min | Other: Podocyte numerical density and number per glomerulus, Measured by light microscopy from tissue obtained by renal biopsy, 4 hours|Foot process width of glomeruli, Measured by electron microscopy from tissue obtained by renal biopsy, 4 hours|Detachment and endothelial fenestration of glomeruli, Measured by electron microscopy from tissue obtained by renal biopsy, 4 hours|Podocyte volume of glomeruli, Measured by electron microscopy from tissue obtained by renal biopsy, 4 hours|Number and identity of RNA in kidney cells, Measured from tissue obtained by renal biopsy, 4 hours|Epigenetic profiling, Measured from tissue obtained by renal biopsy, 4 hours
Sponsor/Collaborators: Sponsor: University of Colorado, Denver
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1|PHASE2
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2018-10-01
Completion Date: 2023-10-30
Results First Posted:
Last Update Posted: 2023-08-15
Locations: Children's Hospital Colorado, Aurora, Colorado, 80238, United States
URL: https://clinicaltrials.gov/show/NCT03584217