Clinical Trial: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia

Brief Summary: The objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods for the study of functional microcirculation.

Detailed Summary:

The EETY study is a single-center proof of concept study in healthy volunteers. The main objective is to study the involvement of epoxy-eicosatrienoic acids (EETs) in the reactivity of cutaneous microcirculation during post-occlusive hyperemia and thermal hyperemia, by studying the response to microdialysis of fluconazole (an inhibitor of EETs) versus control, on the forearm.

Response is measured by the amplitude of the post-occlusive hyperemia and thermal hyperemia peaks (maximum amplitude as a percentage of maximal vasodilation and areas under the curve: AUC) during the injection of fluconazole compared to an intradermal injection of solvent (NaCl 9 ‰).

The subjects are healthy volunteers of both sexes, aged between 18 and 35, non-smokers and in good health. Over two years, 30 subjects will be included in the study for 6 to 13 weeks.


Sponsor: University Hospital, Grenoble

Current Primary Outcome: Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole compared with injection of vehicle (NaCl 9 ‰) [ Time Frame: 2 hours ]

maximum amplitude as a percentage of maximal vasodilation and area under the curve: AUC


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole, at 2 concentrations, or vehicle (NaCl 9 ‰) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC
  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without ANESDERM ® (lidocaine, prilocaine) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC
  • Amplitude of the post-occlusive hyperemia and thermal hyperemia following the injection by intradermal microdialysis of fluconazole or vehicle (NaCl 9 ‰), with and without N(G)-nitro-L-arginine-methyl ester (L-NMMA) [ Time Frame: 2 hours ]
    maximum amplitude expressed as percentage of maximal vasodilation and AUC


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: February 3, 2011
Date Started: February 2011
Date Completion:
Last Updated: September 4, 2012
Last Verified: September 2012