Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 Drug: Placebo |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 28 |
| Study Start Date: | August 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Rosiglitazone |
Drug: Rosiglitazone
4 mg tablets, bid, 12 months
|
| Placebo Comparator: placebo |
Drug: Placebo
2 tablets per day
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Germany | |
| University hospital Dresden | |
| Dresden, Germany, 01307 | |
| Principal Investigator: | Frank Pistrosch, M.D. | Nephrology, Department of Medicine, University hospital Dresden |
More Information
No publications provided by Dresden University of Technology
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00324675 History of Changes |
| Other Study ID Numbers: | DN 2 |
| Study First Received: | May 9, 2006 |
| Results First Received: | September 15, 2011 |
| Last Updated: | October 27, 2011 |
| 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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Kidney Diseases Proteinuria Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Urologic Diseases Diabetes Complications Urination Disorders Urological Manifestations Signs and Symptoms Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013