Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324675
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2006-05-09
Brief Title:
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Status:
COMPLETED
Status Verified Date:
2011-10
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:
None
Brief Summary:
Objective
To evaluate how rosiglitazone does influence the renal plasma flow the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy
Background
Diabetic nephropathy is a world wide public health concern of increasing proportions It has become the most common single cause of end-stage renal disease in the United States and in Europe Previous studies have already found agents modifying the renin-angiotensin-system ACE inhibitors and angiotensin receptor blocker to retard diabetic nephropathy These agents are likely to exert multiple effects in the kidney One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics
In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone In that study rosiglitazone significantly reduced glomerular hyperfiltration This was associated with a reduction of urinary albumin excretion The observed effects are potentially important in the context of renal protection provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy renal insufficiency hypertension proteinuria
Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy
To evaluate how rosiglitazone does influence the renal plasma flow the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy
Background
Diabetic nephropathy is a world wide public health concern of increasing proportions It has become the most common single cause of end-stage renal disease in the United States and in Europe Previous studies have already found agents modifying the renin-angiotensin-system ACE inhibitors and angiotensin receptor blocker to retard diabetic nephropathy These agents are likely to exert multiple effects in the kidney One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics
In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone In that study rosiglitazone significantly reduced glomerular hyperfiltration This was associated with a reduction of urinary albumin excretion The observed effects are potentially important in the context of renal protection provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy renal insufficiency hypertension proteinuria
Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None