ET-blockade and Exercise Induced Blood Flow in T2DM

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Radboud University

ClinicalTrials.gov Identifier:

NCT01779596

First received: January 28, 2013

Last updated: NA

Last verified: February 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 28, 2013
Last Updated Date	January 28, 2013
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 28, 2013)	exercise induced blood flow [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 28, 2013)	exercise induced Flow Mediated Dilation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	ET-blockade and Exercise Induced Blood Flow in T2DM
Official Title ^ICMJE	Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: Bosentan Other Names: Bosentan Tracleer actelion pharmaceuticals 125 mg oral dose Drug: Placebo Other Names: Placebo actelion pharmaceuticals 125 mg oral dose
Study Arm (s)	Experimental: Bosentan Single dose of Bosentan (125 mg) Intervention: Drug: Bosentan Placebo Comparator: Placebo Single dose of placebo (125 mg) Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	22
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	40 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01779596
Other Study ID Numbers ^ICMJE	ET-EX-ACUTE
Has Data Monitoring Committee	No
Responsible Party	Radboud University
Study Sponsor ^ICMJE	Radboud University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Radboud University
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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