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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

NCT ID: NCT00324675

Last Updated: 2011-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Overt Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Rosiglitazone

Group Type ACTIVE_COMPARATOR

Rosiglitazone

Intervention Type DRUG

4 mg tablets, bid, 12 months

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 tablets per day

Interventions

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Rosiglitazone

4 mg tablets, bid, 12 months

Intervention Type DRUG

Placebo

2 tablets per day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Pistrosch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nephrology, Department of Medicine, University hospital Dresden

Locations

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University hospital Dresden

Dresden, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22723267 (View on PubMed)

Other Identifiers

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DN 2

Identifier Type: -

Identifier Source: org_study_id