ET-blockade and Exercise Induced Blood Flow in T2DM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bosentan

Single dose of Bosentan (125 mg)

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

Placebo

Single dose of placebo (125 mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Bosentan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Tracleer actelion pharmaceuticals 125 mg oral dose actelion pharmaceuticals 125 mg oral dose

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes