Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05193981
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2022-01-03
Brief Title:
A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Role of Homocysteine Metabolism Endothelial Function and Microvascular Rarefaction on Renal Disease Severity and Progression in ADPKD
Status:
RECRUITING
Status Verified Date:
2024-04
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:
HCY
Brief Summary:
The purpose of this study is to assess homocysteine metabolism and systemic endothelial function at the early stages of the disease and determine the prognostic value of homocysteine related metabolites and markers of endothelial function and injury to estimate renal disease severity and progression in patients with early Autosomal Dominant Polycystic Kidney Disease ADPKD
Detailed Description:
ADPKD is a devastating systemic disorder characterized by progressive development and enlargement of bilateral renal cysts often leading to renal failure Disease severity and progression vary widely among patients Large phenotypic variability incomplete understanding of underlying mechanisms and lack of suitable biomarkers challenge potential therapies identification implementation and evaluation
In ADPKD systemic endothelial dysfunction ED characterized by an imbalance between vasodilating particularly nitric oxide NO and vasoconstricting substances develops early and correlates with renal disease severity It has been previously associated with decreased NO availability but NO abnormalities mechanisms are still poorly understood Endothelium-dependent NO-mediated vasodilation is impaired in subjects with hyperhomocysteinemia suggesting that NO availability is decreased in these subjects Increased plasma levels of homocysteine have been reported in patients with ADPKD and preserved kidney function likely contributing to a reduction in NO bioavailability The mechanisms underlying increased homocysteine in ADPKD are not known Furthermore whether systemic endothelial function and injury or homocysteine levels can predict renal disease severity and progression in patients is unknown
The investigators broad objective is to assess homocysteine metabolism and systemic endothelial function at the early stages of the disease and determine the prognostic value of homocysteine related metabolites and markers of endothelial function and injury to estimate renal disease severity and progression in patients with early ADPKD
Participants in this study will have a blood and a urine sample collected to determine biomarkers of oxidative stress endothelial function and injury homocysteine and related metabolite levels In addition peripheral arterial tonometry PAT will determine systemic endothelial function and an abdominal MRI will be performed to determine the patients total kidney volume TKV
In ADPKD systemic endothelial dysfunction ED characterized by an imbalance between vasodilating particularly nitric oxide NO and vasoconstricting substances develops early and correlates with renal disease severity It has been previously associated with decreased NO availability but NO abnormalities mechanisms are still poorly understood Endothelium-dependent NO-mediated vasodilation is impaired in subjects with hyperhomocysteinemia suggesting that NO availability is decreased in these subjects Increased plasma levels of homocysteine have been reported in patients with ADPKD and preserved kidney function likely contributing to a reduction in NO bioavailability The mechanisms underlying increased homocysteine in ADPKD are not known Furthermore whether systemic endothelial function and injury or homocysteine levels can predict renal disease severity and progression in patients is unknown
The investigators broad objective is to assess homocysteine metabolism and systemic endothelial function at the early stages of the disease and determine the prognostic value of homocysteine related metabolites and markers of endothelial function and injury to estimate renal disease severity and progression in patients with early ADPKD
Participants in this study will have a blood and a urine sample collected to determine biomarkers of oxidative stress endothelial function and injury homocysteine and related metabolite levels In addition peripheral arterial tonometry PAT will determine systemic endothelial function and an abdominal MRI will be performed to determine the patients total kidney volume TKV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK128017-01 | NIH | None | httpsreporternihgovquickSearch1R01DK128017-01 |