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ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01779609
Collaborator
Actelion (Industry)
19
Enrollment
1
Location
3
Arms
44
Duration (Months)
0.4
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 vascular adaptations during an 8-week exercise program 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 :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bosentan + Exercise

2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise

Drug: Bosentan
Other Names:
  • Tracleer
  • actelion pharmaceuticals

    • Behavioral: Exercise
    Supervised exercise training program of 8 weeks, for 3x/week
    Other Names:
  • Supervised Exercise Training Program

    		•
    Placebo Comparator: Placebo + Exercise

    2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise

    Drug: Placebo
    Other Names:
  • actelion pharmaceuticals

    • Behavioral: Exercise
    Supervised exercise training program of 8 weeks, for 3x/week
    Other Names:
  • Supervised Exercise Training Program

    		•
    Other: Exercise

    3x/week supervised exercise for 8 weeks

    Behavioral: Exercise
    Supervised exercise training program of 8 weeks, for 3x/week
    Other Names:
  • Supervised Exercise Training Program

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Flow mediated dilation [8 weeks]

    Secondary Outcome Measures

    1. Conduit Artery Dilator Capacity [8 weeks]

    2. Intima-Media Thickness [8 weeks]

    3. Maximal Oxygen Uptake [8 weeks]

    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
    • Actelion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01779609
    Other Study ID Numbers:
    • ET-EX-TRAINING
    First Posted:
    Jan 30, 2013
    Last Update Posted:
    May 5, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Bosentan

    Study Results

    No Results Posted as of May 5, 2016