Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline
Secondary Outcomes
- sICAM-1 plasma levels
- hs-CRP
- fibrinogen
- urinary 11-dehydroTXB2