Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
Public ClinicalTrials.gov record NCT04074668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CROCODILE Study: Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04074668
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Interventions
- Aminohippurate Sodium Inj 20% Drug
- Iohexol Inj 300 milligrams/milliliter (mg/ml) Drug
- PET/CT Scan Radiation
- Renal Biopsy Procedure
Drug · Radiation · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 30 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2019
- Primary completion
- May 14, 2022
- Completion
- Nov 14, 2022
- Last update posted
- Feb 8, 2023
2020 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Diabetes trials
Other public records listing Diabetes. Sorted by last update posted; newest first. Not a recommendation.
- NCT07784127: Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation Not yet recruiting
- NCT02262806: Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy Active, not recruiting
- NCT07748858: Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities Recruiting
- NCT05561595: Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma Recruiting
- NCT05912647: Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes Recruiting
- NCT07676188: Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD) Not yet recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04074668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2023 · Synced Sep 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04074668 live on ClinicalTrials.gov.