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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00324792
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : June 13, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Leucotrienes Drug: intensive insulin therapy Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of an Intensive Insulin Therapy on the Production of LTE4 in Patients With Diabetes
Study Start Date : May 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. urinary 11-dehydroTXB2
  2. hs-CRP
  3. fibrinogen
  4. sICAM-1 plasma levels


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324792


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00324792    
Other Study ID Numbers: DCIC 05 54
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs