ET-blockade and Exercise Induced Blood Flow in T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779596
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):
Radboud University

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
Type 2 Diabetes Mellitus Drug: Bosentan Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
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 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

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

Primary Outcome Measures :
  1. exercise induced blood flow [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. exercise induced Flow Mediated Dilation [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779596

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6525 EX
Sponsors and Collaborators
Radboud University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Radboud University Identifier: NCT01779596     History of Changes
Other Study ID Numbers: ET-EX-ACUTE
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Radboud University:
endothelial function
blood flow

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action