Back to resultsET-blockade and Exercise Induced Blood Flow in T2DM
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Bosentan
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring diabetes, endothelial function, exercise, blood flow, bosentan
Eligibility Criteria
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
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bosentan
Placebo
Arm Description
Single dose of Bosentan (125 mg)
Single dose of placebo (125 mg)
Outcomes
Primary Outcome Measures
exercise induced blood flow
Secondary Outcome Measures
exercise induced Flow Mediated Dilation
Full Information
NCT ID
NCT01779596
First Posted
January 28, 2013
Last Updated
May 3, 2016
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01779596
Brief Title
ET-blockade and Exercise Induced Blood Flow in T2DM
Official Title
Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, endothelial function, exercise, blood flow, bosentan
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Single dose of Bosentan (125 mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo (125 mg)
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer, actelion pharmaceuticals, 125 mg oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
actelion pharmaceuticals, 125 mg oral dose
Primary Outcome Measure Information:
Title
exercise induced blood flow
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
exercise induced Flow Mediated Dilation
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 EX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24928953
Citation
Schreuder TH, van Lotringen JH, Hopman MT, Thijssen DH. Impact of endothelin blockade on acute exercise-induced changes in blood flow and endothelial function in type 2 diabetes mellitus. Exp Physiol. 2014 Sep;99(9):1253-64. doi: 10.1113/expphysiol.2013.077297. Epub 2014 May 16.
Results Reference
derived
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ET-blockade and Exercise Induced Blood Flow in T2DM
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