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NCT04074668 · ClinicalTrials.gov registry record
Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 58
- Enrollment target
NCT04074668: Completed study, sponsored by University of Colorado, Denver.
NCT04074668 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04074668 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
Study Summary
Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. By examining the interplay between factors responsible for increased renal adenosine triphosphate (ATP) consumption and decreased ATP generation in young adults with and without T1D, this study hopes to identify novel therapeutic targets to impede the development of DKD in future trials. The investigators propose to address the specific aims in a cross-sectional study with 30 adults with T1D and 20 controls without a diagnosis of diabetes. For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a Dual-energy X-Ray Absorptiometry (DXA) scan to assess body composition, renal Magnetic Resonance Imaging (MRI) to quantify renal oxygenation and perfusion, and a Positron Emission Tomography/Computed Tomography (PET/CT) scan to quantify renal O2 consumption. After the PET and MRI, participants will undergo a hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp. To further investigate the mechanisms of renal damage in T1D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.
Primary Outcome
Blood oxygen level dependent (BOLD) MRI
Interventions
- DRUG Aminohippurate Sodium Inj 20%
- PROCEDURE Renal Biopsy
- RADIATION PET/CT Scan
- DRUG Iohexol Inj 300 milligrams/milliliter (mg/ml)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2022-11-15 |
What the finished NCT04074668 record still lists
NCT04074668 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Aminohippurate Sodium Inj 20% is the first listed.
NCT04074668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04074668 about?
NCT04074668 is a clinical study titled "Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance". Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxi...
What is the current status of trial NCT04074668?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2020-01-01. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04074668?
The interventions under investigation include: Aminohippurate Sodium Inj 20% (DRUG), Renal Biopsy (PROCEDURE), PET/CT Scan (RADIATION), Iohexol Inj 300 milligrams/milliliter (mg/ml) (DRUG).
Who is sponsoring clinical trial NCT04074668?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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