- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779609
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
May 4, 2016 updated by: Radboud University Medical Center
Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 EX
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Other Names:
Supervised exercise training program of 8 weeks, for 3x/week
Other Names:
|
Placebo Comparator: 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
|
Other Names:
Supervised exercise training program of 8 weeks, for 3x/week
Other Names:
|
Other: Exercise
3x/week supervised exercise for 8 weeks
|
Supervised exercise training program of 8 weeks, for 3x/week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Flow mediated dilation
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Conduit Artery Dilator Capacity
Time Frame: 8 weeks
|
8 weeks
|
Intima-Media Thickness
Time Frame: 8 weeks
|
8 weeks
|
Maximal Oxygen Uptake
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimate)
January 30, 2013
Study Record Updates
Last Update Posted (Estimate)
May 5, 2016
Last Update Submitted That Met QC Criteria
May 4, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET-EX-TRAINING
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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