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ET-blockade and Exercise Induced Blood Flow in T2DM

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01779596
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
31
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bosentan

Single dose of Bosentan (125 mg)

Drug: Bosentan
Other Names:
  • Tracleer
  • actelion pharmaceuticals
  • 125 mg oral dose

    		•
    Placebo Comparator: Placebo

    Single dose of placebo (125 mg)

    Drug: Placebo
    Other Names:
  • actelion pharmaceuticals
  • 125 mg oral dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. exercise induced blood flow [2 hours]

    Secondary Outcome Measures

    1. exercise induced Flow Mediated Dilation [2 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls
    Exclusion Criteria:

    • <40 years of age

    • 65 years of age

    • smoking

    • cardiovascular disease

    • diabetes related manifest vascular complications

    • Type 1 Diabetes Mellitus

    • use of Glibenclamide

    • use of HIV drugs

    • use of calcineurin inhibitors

    • use of drugs that interfere with CYP3A4 and CYP2C19

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Nijmegen Medical Centre Nijmegen Gelderland Netherlands 6525 EX

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01779596
    Other Study ID Numbers:
    • ET-EX-ACUTE
    First Posted:
    Jan 30, 2013
    Last Update Posted:
    May 4, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Radboud University Medical Center
    diabetes
    endothelial function
    exercise
    blood flow
    bosentan
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Bosentan

    Study Results

    No Results Posted as of May 4, 2016