Diabetes Mellitus Clinical Trial
Official title:
Effects of Pioglitazone on Endothelial Progenitor Cells in Type 2 Diabetic Patients With Vascular Complications - The SPLENDOR Study.
The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects with cardiovascular disease.
Diabetes is one of the most common chronic diseases worldwide, affecting nearly 200 million
people, almost all suffering from Type 2 Diabetes. It is the fourth leading cause of death
in developed countries due to the negative impact of the disease on the cardiovascular
system. Treatment, aimed to the reduction of this intrinsic cardiovascular risk, is based on
tight control of glucose and all coexisting metabolic abnormalities as well as of biomarkers
of inflammation and atherogenesis.
Macrovascular complications account for the vast majority of morbidity and mortality in
diabetic patients, and there is growing evidence that pathophysiologic mechanisms other than
hyperglycemia are responsible. The condition of the vascular endothelium in particular has
been shown to effect the health and disease of the cardiovascular system.
The number and function of endothelial progenitor cells correlate inversely with
cardiovascular risk factors and may be a surrogate biologic marker for vascular function and
cumulative cardiovascular risk.
Pioglitazone is an orally active thiazolidinedione derivative. It is a ligand for peroxisome
proliferator-activated receptor-gamma activation that alters transcription of various genes
regulating carbohydrate and lipid metabolism.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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