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Clinical Trial Details

Trial ID: L3762
Source ID: NCT04074668
Associated Drug: Aminohippurate Sodium Inj 20%
Title: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
Acronym: CROCODILE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Kidney Disease|Type 1 Diabetes|Diabetes|Diabetes Mellitus|Diabetes Complications|Diabetic Nephropathies|Type1diabetes|Diabetes, Autoimmune|Autoimmune Diabetes|Juvenile Diabetes|Type 1 Diabetes Mellitus
Interventions: DRUG: Aminohippurate Sodium Inj 20%|DRUG: Iohexol Inj 300 milligrams/milliliter (mg/ml)|RADIATION: PET/CT Scan|PROCEDURE: Renal Biopsy
Outcome Measures: Primary: Renal Oxygenation, Blood oxygen level dependent (BOLD) MRI, 30 minutes|Renal Perfusion, Arterial Spin Labeling (ASL) MRI, 30 minutes|Renal Oxygen Consumption, 11-C Acetate PET/CT, 30 minutes|Insulin Sensitivity, Hyperinsulinemic-Euglycemic Clamp, 4.5 hours|Mitochondrial Function, Blood draw for mitochondrial DNA copy number, 5 minutes|Mitochondrial Function, Blood draw for untargeted metabolite assessment of the tricyclic acid (TCA) cycle, 5 minutes|Mitochondrial Function, Blood draw for targeted assessment and quantification of glucose oxidation using an established metabolite panel, 5 minutes|Mitochondrial Function, Blood draw for untargeted metabolite assessment of Free Fatty Acid (FFA) oxidation, 5 minutes | Secondary: Glomerular Filtration Rate (GFR), Iohexol Clearance Study, 3 hours|Effective Renal Plasma Flow (ERPF), PAH Clearance Study, 2.5 hours|Renin-Angiotensin-Aldosterone-System Activity, Blood draw for Plasma Renin levels, 5 minutes|Renin-Angiotensin-Aldosterone-System Activity, Blood draw for Angiotensin II levels, 5 minutes|Renin-Angiotensin-Aldosterone-System Activity, Blood draw for Copeptin levels, 5 minutes|Kidney Injury Biomarkers, Blood draw for Tyrosine Lysine Leucine-40 (YKL-40) levels, 5 minutes|Kidney Injury Biomarkers, Blood draw for Neutrophil gelatinase-associated lipocalin (NGAL) levels, 5 minutes|Kidney Injury Biomarkers, Blood draw for Kidney Injury Marker 1 (KIM-1) levels, 5 minutes|Kidney Injury Biomarkers, Blood draw for Interleukin-18 (IL-18) levels, 5 minutes|Kidney Injury Biomarkers, Blood draw for Tumor Necrosis Factor Receptor 1/2 (TNF-R 1/2) levels, 5 minutes | 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 | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT
Phases:
Enrollment: 58
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2022-11-15
Results First Posted:
Last Update Posted: 2023-02-09
Locations: Children's Hospital Colorado, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT04074668