Diabetes Clinical Trial
Official title:
Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.
Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the
development of diabetic retinopathy are incompletely understood and include alterations in
bone marrow derived vasculogenic cells called "endothelial progenitor cells".
Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and
hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate
has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the
mechanisms that drive the development of this complication.
Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC
levels in diabetic patients with retinopathy, compared to placebo.
Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the
development of diabetic retinopathy are incompletely understood and include alterations in
bone marrow derived vasculogenic cells called "endothelial progenitor cells".
Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and
hypertriglyceridemia. In addition to lowering triglyceride-rich lipoproteins, PPAR-alpha
agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as
reduction of inflammation. In a trial conducted in type 2 diabetic patients, the drug
fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug
on the mechanisms that drive the development of this complication.
Preliminary data of ours on the effects of fenofibrate on cultured EPC show that this drug
has the potential to improve EPC and, consequently, may benefit patients with retinopathy.
Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC
levels in diabetic patients with retinopathy, compared to placebo.
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