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ET-blockade and Exercise Induced Blood Flow in T2DM

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779596
First Posted: January 30, 2013
Last Update Posted: May 4, 2016
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.
Information provided by (Responsible Party):
Radboud University
  Purpose
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 Intervention Phase
Type 2 Diabetes Mellitus Drug: Bosentan Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

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

Enrollment: 22
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01779596


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01779596     History of Changes
Other Study ID Numbers: ET-EX-ACUTE
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Radboud University:
diabetes
endothelial function
exercise
blood flow
bosentan

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