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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Insulin; Insulin, Globin Zinc

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