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ET-blockade and Exercise-induced Vascular Adaptations in T2DM

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01779609
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 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Flow mediated dilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conduit Artery Dilator Capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Intima-Media Thickness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Maximal Oxygen Uptake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2010
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 + 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:
  • Bosentan
  • 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 Names:
  • Placebo
  • 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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779609

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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01779609     History of Changes
Other Study ID Numbers: ET-EX-TRAINING
Study First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 May 16, 2013