Abstract
Background:
Diabetic patients present with an accelerated atherosclerotic process and an increased risk for future cardiovascular events. In addition to the risk imposed by the disease itself, pharmacological treatment adds also a sizable risk, especially if certain classes of antidiabetic drugs are employed. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors have anti-atherosclerotic effects, yet clinical data are scarcely available.
Design:
We plan to prospectively investigate the effects of dipeptidyl peptidase-4 inhibition with vildagliptin on a number of atherothrombotic markers and adipokines in patients with proven atherosclerosis and type 2 diabetes. The selected markers are: interleukin-6, high sensitivity C reactive protein, interleukin 1-beta, total adiponectin levels, matrix metallo-proteinase 9 and platelet reactivity testing. Sixty eligible patients will be randomized in a 2:1 ratio to vildagliptin/metformin or metformin only treatment, for a 3-month duration treatment. Blood sampling for the proposed investigations will be taken at enrollment and immediately after completion of the study period.
Discussion:
Demonstrating antiatherothrombotic properties of dipeptidyl peptidase-4 inhibitors on proven markers is of substantial clinical significance. Coupled with their proven good safety profile these findings could translate into a significant clinical benefit.
Publication types
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Randomized Controlled Trial
MeSH terms
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Adamantane / adverse effects
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Adamantane / analogs & derivatives*
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Adamantane / therapeutic use
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Adiponectin / blood
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Atherosclerosis / blood
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Atherosclerosis / drug therapy*
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Atherosclerosis / etiology
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Biomarkers / blood
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C-Reactive Protein / metabolism
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Diabetes Mellitus, Type 2 / blood
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Diabetes Mellitus, Type 2 / complications
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Diabetes Mellitus, Type 2 / drug therapy*
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Diabetic Angiopathies / blood
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Diabetic Angiopathies / drug therapy*
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Diabetic Angiopathies / etiology
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Dipeptidyl-Peptidase IV Inhibitors / adverse effects
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Dipeptidyl-Peptidase IV Inhibitors / therapeutic use*
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Drug Combinations
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Humans
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Hypoglycemic Agents / adverse effects
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Hypoglycemic Agents / therapeutic use*
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Inflammation / blood
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Inflammation / drug therapy*
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Inflammation / etiology
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Inflammation Mediators / blood
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Interleukin-1beta / blood
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Interleukin-6 / blood
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Israel
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Matrix Metalloproteinase 9 / blood
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Metformin / adverse effects
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Metformin / therapeutic use*
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Nitriles / adverse effects
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Nitriles / therapeutic use*
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Platelet Function Tests
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Prospective Studies
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Pyrrolidines / adverse effects
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Pyrrolidines / therapeutic use*
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Research Design*
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Thrombosis / blood
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Thrombosis / drug therapy*
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Thrombosis / etiology
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Time Factors
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Treatment Outcome
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Vildagliptin
Substances
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ADIPOQ protein, human
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Adiponectin
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Biomarkers
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Dipeptidyl-Peptidase IV Inhibitors
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Drug Combinations
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Hypoglycemic Agents
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IL6 protein, human
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Inflammation Mediators
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Interleukin-1beta
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Interleukin-6
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Nitriles
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Pyrrolidines
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C-Reactive Protein
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Metformin
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Matrix Metalloproteinase 9
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Vildagliptin
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Adamantane