University hospital Dresden
Dresden, 01307, Germany
NCT Number: NCT00324675
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.
Looking for future studies?
Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Dresden, 01307, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
type 2 diabetes mellitus -age between 40 and 75 years -well controlled HbA1c (< 7.5%) -chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation) -proteinuria > 300 mg / 24 hours
Exclusion criteria
type 1 diabetes -poorly controlled type 2 diabetes (HbA1c > 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value -CHF (more than grade 1 of NYHA) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women
4 mg tablets, bid, 12 months
2 tablets per day
Time frame: at baseline and after 6 and 12 mo of treatment
Time frame: at baseline and after 6 and 12 mo of tretament
Time frame: at abseline and after 6 and 12 mo
Time frame: every month or at occurence
Time frame: at baseline and after 6 and 12 mo
Technische Universität Dresden
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00364988
Chronic Disease, Diabetes Complications
View Trial DetailsNCT07672639
Chronic Disease, Chronic Kidney Disease
Beijing, Beijing Municipality, China
View Trial DetailsNCT06376240
Cardiovascular Diseases, Diabetes Complications
Maastricht, Netherlands
View Trial DetailsNCT07498894
Diabetes Complications, Diabetes Mellitus
Denizli, Turkey (Türkiye)
View Trial Details