ET-blockade and Exercise Induced Blood Flow 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:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01779596
First received: January 28, 2013
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • exercise induced Flow Mediated Dilation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated 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:
  • Bosentan
  • Tracleer
  • actelion pharmaceuticals
  • 125 mg oral dose
Placebo Comparator: Placebo
Single dose of placebo (125 mg)
Drug: Placebo
Other Names:
  • Placebo
  • actelion pharmaceuticals
  • 125 mg oral dose

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01779596

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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01779596     History of Changes
Other Study ID Numbers: ET-EX-ACUTE
Study First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014