ET-blockade and Exercise-induced Vascular Adaptations 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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

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 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.

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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

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bosentan + Exercise

2x/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

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

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

Placebo + Exercise

2x/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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

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

Exercise

3x/week supervised exercise for 8 weeks

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Bosentan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Tracleer actelion pharmaceuticals actelion pharmaceuticals Supervised Exercise Training Program

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