Status:
COMPLETED
I3LTE4: Intensive Insulin Therapy and Production of LTE4 in Patients With Diabetes
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Diabetes Mellitus
Leucotrienes
Eligibility:
All Genders
18+ years
Phase:
NA
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00324792
Start Date
May 1 2006
End Date
October 1 2007
Last Update
June 13 2008
Active Locations (1)
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1
Département d'urologie, néphrologie et endocrinologie-University Hospital of Grenoble
Grenoble, France, 38043