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Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

This study is currently recruiting participants.
Verified by Dresden University of Technology, October 2007

Sponsored by: Dresden University of Technology
Information provided by: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00324675
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Overt Diabetic Nephropathy
Drug: Rosiglitazone

MedlinePlus related topics:   Diabetes    Diabetic Kidney Problems   

ChemIDplus related topics:   Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

Further study details as provided by Dresden University of Technology:

Estimated Enrollment:   34
Study Start Date:   August 2006

  Eligibility
Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324675

Contacts
Contact: Frank Pistrosch, M.D.     0049 351 458 3510     frankpistrosch@hotmail.com    
Contact: Peter Gross, M.D.     0049 351 458 4233    

Locations
Germany
University hospital Dresden     Recruiting
      Dresden, Germany, 01307
      Contact: Frank Pistrosch, M.D.     0049 351 458 3510     frankpistrosch@hotamil.com    

Sponsors and Collaborators
Dresden University of Technology

Investigators
Principal Investigator:     Frank Pistrosch, M.D.     Nephrology, Department of Medicine, University hospital Dresden    
  More Information


Study ID Numbers:   DN 2
First Received:   May 9, 2006
Last Updated:   October 19, 2007
ClinicalTrials.gov Identifier:   NCT00324675
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
type 2 diabetes,  
glomerular filtration rate,  
renal plasma flow,  
endothelial dysfunction,
proteinuria,
diabetic nephropathy

Study placed in the following topic categories:
Renal Insufficiency
Diabetic Nephropathies
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Diabetes Complications

Additional relevant MeSH terms:
Urological Manifestations
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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