ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Radboud University Medical Center19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

BosentanDRUG

PlaceboDRUG

ExerciseBEHAVIORAL

Supervised exercise training program of 8 weeks, for 3x/week

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Flow mediated dilation

Time frame: 8 weeks

Secondary Outcomes

Conduit Artery Dilator Capacity

Time frame: 8 weeks

Intima-Media Thickness

Time frame: 8 weeks

Maximal Oxygen Uptake

Time frame: 8 weeks

Data from ClinicalTrials.gov

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