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Clinical Trial Details

Trial ID: L6227
Source ID: NCT05530356
Associated Drug: Aminohippurate Sodium Inj 20%
Title: Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Acronym: HEIRitage
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Diabetes Type 2|Diabetic Nephropathies|Nephropathy|Obesity|Adolescent Obesity|Diabetic Kidney Disease
Interventions: DRUG: Aminohippurate Sodium Inj 20%|DRUG: Iohexol Inj 300 MG/ML|DRUG: Dextran 40|PROCEDURE: Renal Biopsy|RADIATION: Positron Emission Tomography
Outcome Measures: Primary: Effective Renal Plasma Flow (ERPF), Measured by PAH clearance, 4 Hours|Glomerular Filtration Rate, Measured by Iohexol Clearance, 4 Hours|Glomerular Size Selectivity, Measured by Dextran sieving, 4 hours|Renal Oxygen Availability, Measured by functional kidney MRI, 1 hour|Renal Perfusion, Measured by functional kidney MRI + PET Scan, 1 hour|11-C Acetate Tracer Uptake, Measured by PET Scan, 1 Hour|Renal Oxidative Metabolism, Measured by PET Scan, 1 Hour|Blood Volume Fraction, Measured by PET Scan, 1 Hour|Glomerular Basement Membrane Width, Measured by Renal Biopsy, 1 Hour|Mesangial Expansion, Measured by Renal Biopsy, 1 Hour|Interstitial Fibrosis, Measured by Renal Biopsy, 1 Hour|Renal Arteriosclerosis, Measured by Renal Biopsy, 1 Hour|Spatial Transcriptomics, Measured by Renal Biopsy, 1 Hour|Spatial Metabolomics, Measured by Renal Biopsy, 1 Hour | Secondary: Pulse Wave Velocity between Carotid and Femoral Artery, Measured by PWV, 10 minutes|Whole brain gray matter volume, Measured by brain MRI, 1 Hour|Whole brain cortical thickness, Measured by brain MRI, 1 Hour|Whole brain resting-state network connectivity, Measured by brain MRI, 1 Hour|Age-corrected composite fluid cognition score, Measured by brain MRI, 1 Hour
Sponsor/Collaborators: Sponsor: University of Colorado, Denver
Gender: ALL
Age: CHILD, ADULT
Phases:
Enrollment: 100
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-09-30
Completion Date: 2029-05
Results First Posted:
Last Update Posted: 2022-11-02
Locations: Children's Hospital Colorado, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT05530356