Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04074668
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2019-08-06
Brief Title:
Control of Renal Oxygen Consumption Mitochondrial Dysfunction and Insulin Resistance
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
CROCODILE Study Control of Renal Oxygen Consumption Mitochondrial Dysfunction and Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CROCODILE
Brief 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 Childrens 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 TomographyComputed Tomography PETCT 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
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 Childrens 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 TomographyComputed Tomography PETCT 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None