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

NCT00324675 | Completed Results DMC

• 1 other identifier: DN 2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Overt Diabetic Nephropathy

Keywords

type 2 diabetes,; glomerular filtration rate,; renal plasma flow,; endothelial dysfunction,; proteinuria,; diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• Proteinuria

  at baseline and after 6 and 12 mo of treatment

Secondary Outcomes (4)

• Renal Hemodynamic

  at baseline and after 6 and 12 mo of tretament

• Renal Function

  at abseline and after 6 and 12 mo

• Adverse Event

  every month or at occurence

• HbA1c

  at baseline and after 6 and 12 mo

Study Arms (2)

Rosiglitazone

ACTIVE COMPARATOR

Drug: Rosiglitazone

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rosiglitazone DRUG

4 mg tablets, bid, 12 months

Rosiglitazone

Placebo DRUG

2 tablets per day

placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

University hospital Dresden

Dresden, 01307, Germany

Location

Related Publications (1)

• 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.

  PMID: 22723267 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Proteinuria; Diabetic Nephropathies

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Frank Pistrosch
• Organization: University Hospital "Carl Gustav Carus", Dresden

frank.pistrosch@uniklinikum-dresden.de

0049 351 4400580

Study Officials

• Frank Pistrosch, M.D.

  Nephrology, Department of Medicine, University hospital Dresden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: November 2, 2011
• Results First Posted: October 21, 2011

Record last verified: 2011-10

Locations

DE (1)