Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A New Clinical Utility for Tubular Markers to Identify Kidney Responders to Saxagliptin Treatment in Patients With Diabetic Nephropathy
the study aims to investigate whether treatment with saxagliptin would induce beneficial changes in renal NGAL and L-FABP biomarkers and if they would be used as a tool to identify patients' categories with a particular renal response to DPP-4inhibition. Secondly, to find an association between NGAL and L-FABP, and the relevant renal parameters for both baseline values and rate of changes across defined time points.
Diabetic kidney disease (DKD) is considered a substantial cause of end-stage kidney disease
(ESKD) worldwide. Incorporation of renoprotective options during interventions to prevent the
development of DKD and attenuation of its progression; is of the utmost importance.
Incretin-based therapies, specifically dipeptidyl peptidase 4 (DPP-4) inhibitors exhibited
albuminuria lowering potential beyond their antihyperglycemic effects. Saxagliptin, a potent
selective DPP-4 inhibitor which has been used as monotherapy or in combination with
antidiabetics, has demonstrated great renal efficiency on both experimental and clinical
scale .
Although albumin excretion rate (AER) is a powerful predictor of kidney function
deterioration and progressive renal dysfunction, it is primarily a marker of glomerular
damage and it has some drawbacks. For example; some patients may follow a non-albuminuric
pathway to kidney impairment, others do not progress to macroalbuminuria but remain at
microalbuminuria or even regress to normoalbuminuria. Thus, more sensitive and specific renal
biomarkers than AER will be valuable in predicting early kidney injury and the progression of
diabetic renal damage.
Besides glomerular damage, tubulointerstitial dysfunction largely contributes to the
pathology of diabetic nephropathy. Neutrophil gelatinase-associated lipocalin (NGAL) and
liver type fatty acid binding protein (L-FABP) are apparent as excellent biomarkers of
tubular damage and are earlier predictors of acute kidney injury relative to
microalbuminuria. NGAL is produced by neutrophils, highly expressed in tubular epithelium and
released from tubular cells following damage . L-FABP is expressed in the proximal tubules
and secreted into urine upon tubulointerstitial damage. Clinical significance of these
biomarkers lies in their emergence in normoalbuminuric patients and their association with
increased albuminuria and progression to ESRD with sustained high urinary markers' levels.
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