Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With 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.
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy|
- Proteinuria [ Time Frame: at baseline and after 6 and 12 mo of treatment ] [ Designated as safety issue: No ]
- Renal Hemodynamic [ Time Frame: at baseline and after 6 and 12 mo of tretament ] [ Designated as safety issue: No ]
- Renal Function [ Time Frame: at abseline and after 6 and 12 mo ] [ Designated as safety issue: Yes ]
- Adverse Event [ Time Frame: every month or at occurence ] [ Designated as safety issue: Yes ]
- HbA1c [ Time Frame: at baseline and after 6 and 12 mo ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Rosiglitazone||
4 mg tablets, bid, 12 months
|Placebo Comparator: placebo||
2 tablets per day
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324675
|University hospital Dresden|
|Dresden, Germany, 01307|
|Principal Investigator:||Frank Pistrosch, M.D.||Nephrology, Department of Medicine, University hospital Dresden|