Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03618420
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2018-08-01
Brief Title:
Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
CASPER Study Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASPER
Brief Summary:
Over 125 million Americans have type 1 diabetes T1D increasing risk for early death from cardiorenal disease The strongest risk factor for cardiovascular disease CVD and mortality in T1D is diabetic kidney disease DKD Current treatments such as control of hyperglycemia and hypertension are beneficial but only partially protect against DKD
Hyperfiltration is common in youth with T1D and predicts progressive DKD Hyperfiltration is also associated with early changes in intrarenal hemodynamic function including increased renal plasma flow RPF and glomerular pressure Intrarenal hemodynamic function is strongly influenced by the renin-angiotensin-aldosterone system RAAS which is also considered a key player in the pathogenesis of DKD Preliminary data demonstrate differences in intrarenal hemodynamic function and RAAS activation in early and advanced DKD in T1D However the pathophysiology contributing to the differences observed in RAAS activation and intrarenal hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine vasopressin AVP acts directly to modify intrarenal hemodynamic function but also indirectly by activating RAAS Preliminary data suggest that elevated copeptin a marker of AVP which predicts DKD in T1D adults independently of other risk factors However no human studies to date have examined how copeptin relates to intrarenal hemodynamic function in early DKD in T1D A better understanding of this relationship is critical to inform development of new therapies targeting the AVP system in T1D Accordingly in this study the investigators propose to define the relationship between copeptin and intrarenal hemodynamics in early stages of DKD by studying copeptin levels renal plasma flow and glomerular filtration in youth n50 aged 12-21 y with T1D duration 10 y
Hyperfiltration is common in youth with T1D and predicts progressive DKD Hyperfiltration is also associated with early changes in intrarenal hemodynamic function including increased renal plasma flow RPF and glomerular pressure Intrarenal hemodynamic function is strongly influenced by the renin-angiotensin-aldosterone system RAAS which is also considered a key player in the pathogenesis of DKD Preliminary data demonstrate differences in intrarenal hemodynamic function and RAAS activation in early and advanced DKD in T1D However the pathophysiology contributing to the differences observed in RAAS activation and intrarenal hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine vasopressin AVP acts directly to modify intrarenal hemodynamic function but also indirectly by activating RAAS Preliminary data suggest that elevated copeptin a marker of AVP which predicts DKD in T1D adults independently of other risk factors However no human studies to date have examined how copeptin relates to intrarenal hemodynamic function in early DKD in T1D A better understanding of this relationship is critical to inform development of new therapies targeting the AVP system in T1D Accordingly in this study the investigators propose to define the relationship between copeptin and intrarenal hemodynamics in early stages of DKD by studying copeptin levels renal plasma flow and glomerular filtration in youth n50 aged 12-21 y with T1D duration 10 y
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