Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGBosentan
DRUGPlacebo
BEHAVIORALExercise
Supervised exercise training program of 8 weeks, for 3x/week
Sponsors
Actelion
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow mediated dilation | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Conduit Artery Dilator Capacity | 8 weeks |
| Intima-Media Thickness | 8 weeks |
| Maximal Oxygen Uptake | 8 weeks |
Countries
Netherlands
Outcome results
None listed