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ET-blockade and Exercise Induced Blood Flow in T2DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01779596
First received: January 28, 2013
Last updated: May 3, 2016
Last verified: May 2016

January 28, 2013
May 3, 2016
May 2011
December 2013   (final data collection date for primary outcome measure)
exercise induced blood flow [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01779596 on ClinicalTrials.gov Archive Site
exercise induced Flow Mediated Dilation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ET-blockade and Exercise Induced Blood Flow in T2DM
Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Bosentan
    Other Names:
    • Tracleer
    • actelion pharmaceuticals
    • 125 mg oral dose
  • Drug: Placebo
    Other Names:
    • actelion pharmaceuticals
    • 125 mg oral dose
  • Experimental: Bosentan
    Single dose of Bosentan (125 mg)
    Intervention: Drug: Bosentan
  • Placebo Comparator: Placebo
    Single dose of placebo (125 mg)
    Intervention: Drug: Placebo
Schreuder TH, van Lotringen JH, Hopman MT, Thijssen DH. Impact of endothelin blockade on acute exercise-induced changes in blood flow and endothelial function in type 2 diabetes mellitus. Exp Physiol. 2014 Sep;99(9):1253-64. doi: 10.1113/expphysiol.2013.077297.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
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   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01779596
ET-EX-ACUTE
No
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
Not Provided
Radboud University
May 2016

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