How Does the Diabetes Drug, Pioglitazone, Reduce Protein Loss in the Urine?
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|ClinicalTrials.gov Identifier: NCT00749047|
Recruitment Status : Unknown
Verified September 2009 by Christchurch Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 9, 2008
Last Update Posted : September 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Pioglitazone||Phase 4|
In addition to their insulin sensitising action, thiazolidinediones (TZDs) have beneficial effects on vascular function. These include a decrease in proteinuria and amelioration of diabetic nephropathy. Although the anti-proteinuric effect of TZDs is well established the mechanism(s) underlying these changes has yet to be determined. Possible mechanisms include altered renal haemodynamics, maintenance of anionic electrostatic filtration barriers in the glomerular basement membrane and pleiotropic effects.
The target of TZDs, the peroxisome proliferator-activated receptors (PPARs), directly modulate vessel wall function. The kidney differentially expresses all PPAR isoforms and there is evidence that TZDs have pleiotropic effects in the kidney over and above their metabolic and haemodynamic actions. These effects include a direct action on cultured mesangial cells, inhibition of in vivo mesangial expansion, reduction in podocyte injury, and decreased production of type IV collagen and urinary endothelin-1 levels in early stage diabetic nephropathy.
Glomerular ultrafiltration of plasma proteins is governed by the size of the filtration pores and the extent of anionic sites in the basement membrane and podocyte slit pore junction. It is possible that the anti-proteinuric effect of TZDs is attributable to an increase in size and/or charge selectivity in the glomerular filtration barrier. A Medline search showed there have been no studies on the effect of TZDs on protein ultrafiltration. The aim of the proposed study is to measure urinary protein size and charge selectivity in patients with early stage diabetic nephropathy before and after treatment with the TZD, pioglitazone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study on the Anti-proteinuric Effects of Pioglitazone in Patients With Type 2 Diabetes.|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||March 2010|
Open label arm
- Reduction in proteinuria [ Time Frame: 3 months ]
- Reduction in non-fasting plasma glucose concentration [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749047
|Christchurch, Canterbury, New Zealand, 8001|