Diabetes Mellitus Clinical Trial
Official title:
Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes
The primary objective of the study is to assess the effect of a 3-month intensive insulin therapy on urinary leukotriene E4 (LTE4) excretion in patients with diabetes.
Our group has recently reported the results of a preliminary cross-sectional study, which
demonstrated that the urinary LTE4 excretion is increased in patients with type 1 diabetes.
With regard to recent human genetic studies showing that polymorphisms in the 5-lipoxygenase
(5-LO) promoter and FLAP haplotypes is linked to cardiovascular disease susceptibility our
data suggested the potential interest of LTE4 as a non-invasive biomarker of cardiovascular
risk. In diabetes mellitus, further studies are required to evaluate the 5-LO pathway after
improvement of glucose control and concomitantly with established inflammatory
cardiovascular biomarkers.
The secondary objectives are:
Before and after 3-month intensive insulin therapy- Relationship between a marker of
platelet activation (urinary 11-dehydro-thromboxan B2 :11-dehydroTXB2) and urinary LTE4-
Relationship between inflammatory plasma markers of cardiovascular risk (hs-CRP and
fibrinogen) and urinary LTE4- Relationship between a plasma marker of endothelial
dysfunction (sICAM-1) and urinary LTE4- Changes in LTE4 according to patient subgroups
(patients with type 1 and type 2 diabetes mellitus)
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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