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Completed

NCT Number: NCT01779609

ET-blockade and Exercise-induced Vascular Adaptations in T2DM

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525 EX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

Other names: Tracleer, actelion pharmaceuticals

Placebo

Drug

Other names: actelion pharmaceuticals

Exercise

Behavioral

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

Other names: Supervised Exercise Training Program

Primary outcomes

  1. Flow mediated dilation

    Time frame: 8 weeks

Secondary outcomes

  1. Conduit Artery Dilator Capacity

    Time frame: 8 weeks

  2. Intima-Media Thickness

    Time frame: 8 weeks

  3. Maximal Oxygen Uptake

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Actelion

Registry information

Official study title

Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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