Diabetes Mellitus, Leucotrienes
Conditions
Brief summary
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.
Detailed description
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)
Interventions
Sponsors
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetes mellitus (type 1 or type 2) * \> 18 year-old * subject has given free, informed written consent * subject entitled to health insurance cover * medical follow-up at the department of Diabetology, Grenoble University Hospital * inappropriate glucose control (HbA1c \> 8.5%) requiring an initiation, or revision, of insulin therapy
Exclusion criteria
* legal incapacity or limited legal competence * pregnant women * heart failure * impaired renal function,defined by a creatinin clearance \< 60 ml/mn according to Cockroft formula * asthma * respiratory failure * IV, IM, SC or oral treatment with cortico-steroids for the last 2 months prior to baseline * current smoking \> cigarettes / day * any infectious disease for the last 2 months prior to baseline * baseline CRP \> 20 mg/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary 11-dehydroTXB2 | — |
| hs-CRP | — |
| fibrinogen | — |
| sICAM-1 plasma levels | — |
Countries
France
Outcome results
None listed