ET-blockade and Exercise-induced Vascular Adaptations in T2DM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01779609
First received: January 28, 2013
Last updated: NA
Last verified: February 2010
History: No changes posted

January 28, 2013
January 28, 2013
April 2010
December 2013   (final data collection date for primary outcome measure)
Flow mediated dilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Conduit Artery Dilator Capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Intima-Media Thickness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Maximal Oxygen Uptake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Type 2 Diabetes Mellitus
  • Drug: Bosentan
    Other Names:
    • Bosentan
    • Tracleer
    • actelion pharmaceuticals
  • Drug: Placebo
    Other Names:
    • Placebo
    • actelion pharmaceuticals
  • Behavioral: Exercise
    Supervised exercise training program of 8 weeks, for 3x/week
    Other Name: Supervised Exercise Training Program
  • 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
    Interventions:
    • Drug: Bosentan
    • Behavioral: Exercise
  • 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
    Interventions:
    • Drug: Placebo
    • Behavioral: Exercise
  • Exercise
    3x/week supervised exercise for 8 weeks
    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01779609
ET-EX-TRAINING
No
Radboud University
Radboud University
Actelion
Not Provided
Radboud University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP