Clinical Trial Details
| Trial ID: | L3439 |
| Source ID: | NCT03620773 |
| Associated Drug: | Aminohippurate Sodium Inj 20% |
| Title: | Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes |
| Acronym: | IMPROVE-T2D |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Obesity|Bariatric Surgery Candidate|Nephropathy|Diabetic Kidney Disease|Diabetes Mellitus, Type 2|Diabetes Mellitus|Diabetes Complications|Weight Loss|Diabetic Nephropathies|Adolescent Obesity|Pediatric Obesity |
| Interventions: | DRUG: Aminohippurate Sodium Inj 20%|DRUG: Iohexol Inj 300 mg/mL|PROCEDURE: Vertical Sleeve Gastrectomy|PROCEDURE: Renal Biopsy |
| Outcome Measures: | Primary: Pancreatic β-cell function, Measured by Mixed Meal Tolerance Test (MMTT), 4 hours (MMTT)|Pancreatic β-cell function, Measured by blood draws during/after hyperglycemic clamp, 4 hours (hyperglycemic clamp)|Effective Renal Plasma Flow (ERPF), Measured by PAH clearance, 4 hours|Glomerular Filtration Rate (GFR), Measured by iohexol clearance, 4 hours | Secondary: Renal Perfusion, Measured by Arterial Spin Labeling (ASL) MRI, 10 min|Renal Oxygenation, Measured by Blood Oxygen Level Dependent (BOLD) MRI, 60 min|Aortic Stiffness & Wall Shear Stress, Measured by Aortic MRI, 30 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 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: | 30 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC |
| Start Date: | 2018-10-01 |
| Completion Date: | 2024-10-01 |
| Results First Posted: | |
| Last Update Posted: | 2024-04-05 |
| Locations: | Children's Hospital Colorado, Aurora, Colorado, 80045, United States |
| URL: | https://clinicaltrials.gov/show/NCT03620773 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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