Type 2 Diabetes MellitusPhase 4NCT01779609
ET-blockade and Exercise-induced Vascular Adaptations in T2DM
A Phase 4 study testing Bosentan and Exercise in people with Type 2 Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Bosentan and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls
Who cannot join
- <40 years of age
- >65 years of age
- smoking
- cardiovascular disease
- diabetes related manifest vascular complications
- Type 1 Diabetes Mellitus
Show all 10Show fewer
- use of Glibenclamide
- use of HIV drugs
- use of calcineurin inhibitors
- use of drugs that interfere with CYP3A4 and CYP2C19
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6525 EX
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Bosentan, Placebo, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called Tracleer, actelion pharmaceuticals
PlaceboDrug
Also called actelion pharmaceuticals
ExerciseBehavioural
Also called Supervised Exercise Training Program
Supervised exercise training program of 8 weeks, for 3x/week
| Study group | Role | What they receive |
|---|---|---|
| Bosentan + Exercise | Experimental | 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 Receives: Drug: Bosentan; Behavioral: Exercise |
| Placebo + Exercise | Placebo comparator | 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 Receives: Drug: Placebo; Behavioral: Exercise |
| Exercise | Other | 3x/week supervised exercise for 8 weeks Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
Measured: 8 weeks
Secondary outcomes (3)
Conduit Artery Dilator Capacity
Measured: 8 weeks
Intima-Media Thickness
Measured: 8 weeks
Maximal Oxygen Uptake
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779609
- Sponsor's protocol ID
- ET-EX-TRAINING
- Status last verified
- May 2016
- First submitted
- 28 Jan 2013
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25172889
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT01779609
- Acronym / sponsor ID
- ET-EX-TRAINING
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bosentan + Exercise | Experimental | Drug: Bosentan, Behavioral: Exercise2x/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 |
| Placebo + Exercise | Placebo comparator | Drug: Placebo, Behavioral: Exercise2x/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 |
| Exercise | Other | Behavioral: Exercise3x/week supervised exercise for 8 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls
Key exclusion criteria (10 listed)
- <40 years of age
- >65 years of age
- smoking
- cardiovascular disease
- diabetes related manifest vascular complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosentanAlso: Tracleer, actelion pharmaceuticals | Drug | Bosentan + Exercise |
| PlaceboAlso: actelion pharmaceuticals | Drug | Placebo + Exercise |
| ExerciseAlso: Supervised Exercise Training ProgramSupervised exercise training program of 8 weeks, for 3x/week | Behavioural | Bosentan + Exercise, Exercise, Placebo + Exercise |
Primary outcome
Flow mediated dilation
Time frame: 8 weeks
3 secondary outcomes
Conduit Artery Dilator Capacity
Time frame: 8 weeks
Intima-Media Thickness
Time frame: 8 weeks
Maximal Oxygen Uptake
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 25172889Schreuder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bosentan and Exercise in people with Type 2 Diabetes Mellitus, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.