Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407481
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2020-05-19
Brief Title:
PErfusioN OxyGen ConsUmptIon and ENergetics in ADPKD PENGUIN
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
PENGUIN PErfusioN OxyGen ConsUmptIon and ENergetics in ADPKD
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:
PENGUIN
Brief Summary:
Autosomal dominant polycystic kidney disease ADPKD is the most common monogenic cause of end-stage kidney disease ESKD The disorder is characterized by development and continued growth of multiple cysts requiring renal replacement therapy in 50 of patients by age 60 years However ADPKD is also a complex metabolic disorder defined by insulin resistance IR and mitochondrial dysfunction which may be causally related to cyst expansion kidney function decline and contribute to reduced life expectancy Renal hypoxia stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization is proposed as a novel unifying early pathway in the development and expansion of renal cysts in ADPKD By examining the interplay between renal O2 consumption and energy utilization in young adults with and without ADPKD the investigators hope to identify novel therapeutic targets to impede development of cyst expansion in future trials
The investigators propose to address the specific aims in a cross-sectional study with 20 adults with ADPKD 50 female ages 18-40 years Comparative data will be provided from healthy adults from an ongoing study with similar study design and methods CROCODILE Study Control of Renal Oxygen Consumption Mitochondrial Dysfunction and Insulin Resistance 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 to assess body composition and a 11C-acetate positron emission tomography PETCT scan to quantify renal O2 consumption After the PETCT participants will undergo a hyperinsulinemic-euglycemic clamp while fasting 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
The investigators propose to address the specific aims in a cross-sectional study with 20 adults with ADPKD 50 female ages 18-40 years Comparative data will be provided from healthy adults from an ongoing study with similar study design and methods CROCODILE Study Control of Renal Oxygen Consumption Mitochondrial Dysfunction and Insulin Resistance 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 to assess body composition and a 11C-acetate positron emission tomography PETCT scan to quantify renal O2 consumption After the PETCT participants will undergo a hyperinsulinemic-euglycemic clamp while fasting 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
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