search
Back to results

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

Primary Purpose

Type 2 Diabetes, Overt Diabetic Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rosiglitazone
Placebo
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes,, glomerular filtration rate,, renal plasma flow,, endothelial dysfunction,, proteinuria,, diabetic nephropathy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rosiglitazone

placebo

Arm Description

Outcomes

Primary Outcome Measures

Proteinuria

Secondary Outcome Measures

Renal Hemodynamic
Renal Function
Adverse Event
HbA1c

Full Information

First Posted
May 9, 2006
Last Updated
October 27, 2011
Sponsor
Technische Universität Dresden
search

1. Study Identification

Unique Protocol Identification Number
NCT00324675
Brief Title
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Official Title
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Overt Diabetic Nephropathy
Keywords
type 2 diabetes,, glomerular filtration rate,, renal plasma flow,, endothelial dysfunction,, proteinuria,, diabetic nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosiglitazone
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
4 mg tablets, bid, 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 tablets per day
Primary Outcome Measure Information:
Title
Proteinuria
Time Frame
at baseline and after 6 and 12 mo of treatment
Secondary Outcome Measure Information:
Title
Renal Hemodynamic
Time Frame
at baseline and after 6 and 12 mo of tretament
Title
Renal Function
Time Frame
at abseline and after 6 and 12 mo
Title
Adverse Event
Time Frame
every month or at occurence
Title
HbA1c
Time Frame
at baseline and after 6 and 12 mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Pistrosch, M.D.
Organizational Affiliation
Nephrology, Department of Medicine, University hospital Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22723267
Citation
Pistrosch F, Passauer J, Herbrig K, Schwanebeck U, Gross P, Bornstein SR. Effect of thiazolidinedione treatment on proteinuria and renal hemodynamic in type 2 diabetic patients with overt nephropathy. Horm Metab Res. 2012 Nov;44(12):914-8. doi: 10.1055/s-0032-1314836. Epub 2012 Jun 21.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs