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NCT Number: NCT00324792

I3LTE4: Intensive Insulin Therapy and 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Leucotrienes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département d'urologie, néphrologie et endocrinologie-University Hospital of Grenoble

Grenoble, 38043, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive insulin therapy

Drug

Primary outcomes

  1. changes in urinary LTE4 excretion and HbA1c after 3-month intensive insulin therapy versus baseline

Secondary outcomes

  1. urinary 11-dehydroTXB2

  2. hs-CRP

  3. fibrinogen

  4. sICAM-1 plasma levels

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes

Important dates

Study start
2006
Study completion
2007
First posted
May 11, 2006
Registry last updated
Jun 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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