Back to resultsET-blockade and Exercise-induced Vascular Adaptations in T2DM
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Bosentan
Placebo
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus
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 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Bosentan + Exercise
Placebo + Exercise
Exercise
Arm Description
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
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
3x/week supervised exercise for 8 weeks
Outcomes
Primary Outcome Measures
Flow mediated dilation
Secondary Outcome Measures
Conduit Artery Dilator Capacity
Intima-Media Thickness
Maximal Oxygen Uptake
Full Information
NCT ID
NCT01779609
First Posted
January 28, 2013
Last Updated
May 4, 2016
Sponsor
Radboud University Medical Center
Collaborators
Actelion
1. Study Identification
Unique Protocol Identification Number
NCT01779609
Brief Title
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
Official Title
Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (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
Collaborators
Actelion
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bosentan + Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo + Exercise
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Exercise
Arm Type
Other
Arm Description
3x/week supervised exercise for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer, actelion pharmaceuticals
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
actelion pharmaceuticals
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Supervised Exercise Training Program
Intervention Description
Supervised exercise training program of 8 weeks, for 3x/week
Primary Outcome Measure Information:
Title
Flow mediated dilation
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Conduit Artery Dilator Capacity
Time Frame
8 weeks
Title
Intima-Media Thickness
Time Frame
8 weeks
Title
Maximal Oxygen Uptake
Time Frame
8 weeks
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
25172889
Citation
Schreuder TH, Duncker DJ, Hopman MT, Thijssen DH. Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus. Exp Physiol. 2014 Nov;99(11):1538-47. doi: 10.1113/expphysiol.2014.081182. Epub 2014 Aug 28.
Results Reference
derived
Learn more about this trial
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
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