Type 2 Diabetes Clinical Trial
Official title:
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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