NCT00324792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

First QC Date

May 10, 2006

Last Update Submit

June 11, 2008

Conditions

Diabetes MellitusLeucotrienes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • urinary 11-dehydroTXB2

  • hs-CRP

  • fibrinogen

  • sICAM-1 plasma levels

Interventions

intensive insulin therapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Grenoble, 38043, France

Location

Related Publications (6)

  • Hardy G, Boizel R, Bessard J, Cracowski JL, Bessard G, Halimi S, Stanke-Labesque F. Urinary leukotriene E4 excretion is increased in type 1 diabetic patients: a quantification by liquid chromatography-tandem mass spectrometry. Prostaglandins Other Lipid Mediat. 2005 Dec;78(1-4):291-9. doi: 10.1016/j.prostaglandins.2005.10.001. Epub 2005 Nov 2.

    PMID: 16303623BACKGROUND

  • Hardy G, Vergnaud S, Lunardi J, Peoc'h M, Bessard G, Stanke-Labesque F. 5-lipoxygenase expression and activity in aorta from streptozotocin-induced diabetic rats. Prostaglandins Other Lipid Mediat. 2005 Jan;75(1-4):91-103. doi: 10.1016/j.prostaglandins.2004.10.002.

    PMID: 15789618BACKGROUND

  • Cipollone F, Mezzetti A, Fazia ML, Cuccurullo C, Iezzi A, Ucchino S, Spigonardo F, Bucci M, Cuccurullo F, Prescott SM, Stafforini DM. Association between 5-lipoxygenase expression and plaque instability in humans. Arterioscler Thromb Vasc Biol. 2005 Aug;25(8):1665-70. doi: 10.1161/01.ATV.0000172632.96987.2d. Epub 2005 Jun 2.

    PMID: 15933245BACKGROUND

  • Dwyer JH, Allayee H, Dwyer KM, Fan J, Wu H, Mar R, Lusis AJ, Mehrabian M. Arachidonate 5-lipoxygenase promoter genotype, dietary arachidonic acid, and atherosclerosis. N Engl J Med. 2004 Jan 1;350(1):29-37. doi: 10.1056/NEJMoa025079.

    PMID: 14702425BACKGROUND

  • Helgadottir A, Manolescu A, Thorleifsson G, Gretarsdottir S, Jonsdottir H, Thorsteinsdottir U, Samani NJ, Gudmundsson G, Grant SF, Thorgeirsson G, Sveinbjornsdottir S, Valdimarsson EM, Matthiasson SE, Johannsson H, Gudmundsdottir O, Gurney ME, Sainz J, Thorhallsdottir M, Andresdottir M, Frigge ML, Topol EJ, Kong A, Gudnason V, Hakonarson H, Gulcher JR, Stefansson K. The gene encoding 5-lipoxygenase activating protein confers risk of myocardial infarction and stroke. Nat Genet. 2004 Mar;36(3):233-9. doi: 10.1038/ng1311. Epub 2004 Feb 8.

    PMID: 14770184BACKGROUND

  • Boizel R, Bruttmann G, Benhamou PY, Halimi S, Stanke-Labesque F. Regulation of oxidative stress and inflammation by glycaemic control: evidence for reversible activation of the 5-lipoxygenase pathway in type 1, but not in type 2 diabetes. Diabetologia. 2010 Sep;53(9):2068-70. doi: 10.1007/s00125-010-1822-9. Epub 2010 Jun 10. No abstract available.

    PMID: 20535444DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Robert Boizel, Dr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

May 1, 2006

Study Completion

October 1, 2007

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

FR(1)