ET-blockade and Exercise Induced Blood Flow in T2DM

Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01779596

Enrollment

Registered

2013-01-30

Start date

2011-05-31

Completion date

2013-12-31

Last updated

2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, endothelial function, exercise, blood flow, bosentan

Brief summary

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.

Interventions

DRUGBosentan

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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
exercise induced blood flow	2 hours

Secondary

Measure	Time frame
exercise induced Flow Mediated Dilation	2 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026