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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 ongoing, but not recruiting participants.
First Received: May 9, 2006   Last Updated: December 23, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


Further study details as provided by Dresden University of Technology:

Estimated Enrollment: 34
Study Start Date: August 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosiglitazone
    4 mg tablets, bid, 12 months
  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

Locations
Germany
University hospital Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Frank Pistrosch, M.D. Nephrology, Department of Medicine, University hospital Dresden
  More Information

No publications provided

Study ID Numbers: DN 2
Study First Received: May 9, 2006
Last Updated: December 23, 2009
ClinicalTrials.gov Identifier: NCT00324675     History of Changes
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

Additional relevant MeSH terms:
Renal Insufficiency
Diabetic Nephropathies
Metabolic Diseases
Urination Disorders
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Signs and Symptoms
Urological Manifestations
Proteinuria
Hypoglycemic Agents
Urologic Diseases
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Rosiglitazone
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010