ET-blockade and Exercise-induced Vascular Adaptations in T2DM
Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)
1 other identifier
interventional
19
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started Apr 2010
Longer than P75 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 28, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 5, 2016
May 1, 2016
3.7 years
January 28, 2013
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Flow mediated dilation
8 weeks
Secondary Outcomes (3)
Conduit Artery Dilator Capacity
8 weeks
Intima-Media Thickness
8 weeks
Maximal Oxygen Uptake
8 weeks
Study Arms (3)
Bosentan + Exercise
EXPERIMENTAL2x/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
Placebo + Exercise
PLACEBO COMPARATOR2x/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
Exercise
OTHER3x/week supervised exercise for 8 weeks
Interventions
Supervised exercise training program of 8 weeks, for 3x/week
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes Mellitus (\>2 years since diagnosis) OR controls
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Actelioncollaborator
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6525 EX, Netherlands
Related Publications (1)
Schreuder TH, Duncker DJ, Hopman MT, Thijssen DH. Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus. Exp Physiol. 2014 Nov;99(11):1538-47. doi: 10.1113/expphysiol.2014.081182. Epub 2014 Aug 28.
PMID: 25172889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2013
First Posted
January 30, 2013
Study Start
April 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 5, 2016
Record last verified: 2016-05