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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00324792
First received: May 10, 2006
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Leucotrienes
Drug: intensive insulin therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline

Secondary Outcome Measures:
  • urinary 11-dehydroTXB2
  • hs-CRP
  • fibrinogen
  • sICAM-1 plasma levels

Estimated Enrollment: 45
Study Start Date: May 2006
Study Completion Date: October 2007
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324792

Locations
France
Département d'urologie, néphrologie et endocrinologie-University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Robert Boizel, Dr CHU Grenoble
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00324792     History of Changes
Other Study ID Numbers: DCIC 05 54
Study First Received: May 10, 2006
Last Updated: June 11, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014