Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01101269
Status:
TERMINATED
Last Update Posted:
2017-05-12
First Post:
2010-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease (KXK005).
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.
Detailed Description:
Blockers of renin angiotensin aldosterone system (RAAS) are considered the standard of care in treatment of diabetic nephropathy. Their effects are thought to be through multiple mechanisms, including reducing intraglomerular pressure. However, due to the lack of a sensitive, practical and noninvasive method of monitoring renal hemodynamics, the magnitude of hemodynamic effects of these agents and its contribution to proteinuria reduction has not been studied in humans. At the same time, it is not clear if treatment with blockers of the RAAS have similar renal hemodynamic effects in individuals with and without diabetes and kidney disease.
Up to 36 subjects with type 2 diabetes and more than 150 mg of proteinuria who are on stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) and up to 18 healthy volunteers will be enrolled in this study. Subjects with type 2 diabetes will be asked to stop their ACE inhibitor or ARB medications for 10 days. Between 7 to 10 days after stopping these medications renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured as well for comparison to baseline. Subjects' ACE inhibitors or ARB will be restarted and RBF measurement using CEU and measurement of urine protein excretion will be repeated after 7 days. For comparison, RBF will be measured by CEU in up to 18 healthy volunteers. They will then be started on Lisinopril 10 mg orally once a day for 7 days. On day 7 RBF measurement will be repeated to assess the effect of ACE inhibitors on RBF in healthy individuals as compared to those with diabetic nephropathy.
Up to 36 subjects with type 2 diabetes and more than 150 mg of proteinuria who are on stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) and up to 18 healthy volunteers will be enrolled in this study. Subjects with type 2 diabetes will be asked to stop their ACE inhibitor or ARB medications for 10 days. Between 7 to 10 days after stopping these medications renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured as well for comparison to baseline. Subjects' ACE inhibitors or ARB will be restarted and RBF measurement using CEU and measurement of urine protein excretion will be repeated after 7 days. For comparison, RBF will be measured by CEU in up to 18 healthy volunteers. They will then be started on Lisinopril 10 mg orally once a day for 7 days. On day 7 RBF measurement will be repeated to assess the effect of ACE inhibitors on RBF in healthy individuals as compared to those with diabetic nephropathy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: