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ET-blockade and Exercise-induced Vascular Adaptations in T2DM

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779609
First Posted: January 30, 2013
Last Update Posted: May 5, 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.
Collaborator:
Actelion
Information provided by (Responsible Party):
Radboud University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Bosentan Drug: Placebo Behavioral: Exercise Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Flow mediated dilation [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Conduit Artery Dilator Capacity [ Time Frame: 8 weeks ]
  • Intima-Media Thickness [ Time Frame: 8 weeks ]
  • Maximal Oxygen Uptake [ Time Frame: 8 weeks ]

Enrollment: 19
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Bosentan
Other Names:
  • Tracleer
  • actelion pharmaceuticals
Behavioral: Exercise
Supervised exercise training program of 8 weeks, for 3x/week
Other Name: Supervised Exercise Training Program
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
Drug: Placebo
Other Name: actelion pharmaceuticals
Behavioral: Exercise
Supervised exercise training program of 8 weeks, for 3x/week
Other Name: Supervised Exercise Training Program
Exercise
3x/week supervised exercise for 8 weeks
Behavioral: Exercise
Supervised exercise training program of 8 weeks, for 3x/week
Other Name: Supervised Exercise Training Program

  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): NCT01779609


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01779609     History of Changes
Other Study ID Numbers: ET-EX-TRAINING
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: May 5, 2016
Last Verified: May 2016

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