I3LTE4: Intensive Insulin Therapy and Production of LTE4 in Patients With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Leucotrienes

• Registration Number: NCT00324792
• Lead Sponsor: University Hospital, Grenoble

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Study Completion: 2007-10
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-11
• Last Update Posted: 2008-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline

Secondary Outcome Measures

Name	Time	Method
hs-CRP
fibrinogen
urinary 11-dehydroTXB2
sICAM-1 plasma levels

Trial Locations

Locations (1)

Département d'urologie, néphrologie et endocrinologie-University Hospital of Grenoble; 🇫🇷 Grenoble, France