Endothelial FunctionPANNCT01713374
Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System
A study testing Mental stress, Myogenic activation and Cold pressure test in people with Endothelial Function, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Mental stress, Myogenic activation and Cold pressure test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Mar 2014
- Phase
- Interventional
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.
Who cannot join
- any active disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Studies on the Physiological Meaning of Flow-mediated Constriction, Flow-mediated Dilatation and Vasomotion/Flowmotion: Circadian Variability and Role of the Sympathetic Nervous System.
The purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the three interventions under study will increase FMC while causing a blunting in FMD.
Further, the investigators plan to study the circadian variability of FMC and FMD. The investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the early hours.
- Conditions
- Endothelial Function
- Being tested
- Mental stress, no intervention, Myogenic activation, Cold pressure test
- Keywords
- endothelial function, sympathetic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental stressProcedure or surgery
Subjects will be asked to perform complex mathematic operations at a very fast pace
no interventionOther
control visit
Myogenic activationProcedure or surgery
A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.
Cold pressure testProcedure or surgery
A hand will be placed in ice-cold water.
| Study group | Role | What they receive |
|---|---|---|
| Myogenic activation | Active comparator | Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation Receives: Procedure: Myogenic activation |
| Cold pressure test | Active comparator | Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test Receives: Procedure: Cold pressure test |
| mental stress | Active comparator | Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress Receives: Procedure: Mental stress |
| Control | Active comparator | Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FMD in response to sympathetic activation
Flow-mediated dilation will be measured at rest and during each of the interventions.
Measured: Change in FMD before versus 1 Minute after begin of intervention
Secondary outcomes (1)
Change in FMC during sympathetic activation
Change in Flow-mediated constriction induced by each of the interventions.
Measured: Change in FMC before versus 1 minute after begin of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
- Investigators
- Tommaso Gori, MD PhD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713374
- Sponsor's protocol ID
- PAN-1
- Acronym
- PAN
- Status last verified
- Mar 2015
- First submitted
- 18 Oct 2012
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Physiological Meaning of Flow-mediated Constriction, Flow-mediated Dilatation and Vasomotion/Flowmotion: Circadian Variability and Role of the Sympathetic Nervous System.
- ClinicalTrials.gov ID
- NCT01713374
- Acronym / sponsor ID
- PAN / PAN-1
- Conditions
- Endothelial Function
- Keywords
- endothelial function, sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Oct 2012 (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 determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the three interventions under study will increase FMC while causing a blunting in FMD.
Further, the investigators plan to study the circadian variability of FMC and FMD. The investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the early hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myogenic activation | Active comparator | Procedure: Myogenic activationSubjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation |
| Cold pressure test | Active comparator | Procedure: Cold pressure testSubjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test |
| mental stress | Active comparator | Procedure: Mental stressSubjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress |
| Control | Active comparator | Other: no interventionControl visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.
Key exclusion criteria (1 listed)
- any active disease
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 |
|---|---|---|
| Mental stressSubjects will be asked to perform complex mathematic operations at a very fast pace | Procedure or surgery | mental stress |
| no interventioncontrol visit | Other | Control |
| Myogenic activationA pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises. | Procedure or surgery | Myogenic activation |
| Cold pressure testA hand will be placed in ice-cold water. | Procedure or surgery | Cold pressure test |
Primary outcome
Change in FMD in response to sympathetic activation
Time frame: Change in FMD before versus 1 Minute after begin of intervention
Flow-mediated dilation will be measured at rest and during each of the interventions.
1 secondary outcome
Change in FMC during sympathetic activation
Time frame: Change in FMC before versus 1 minute after begin of each intervention
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 1 Apr 2015.
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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.
Tommaso Gori, MD PhD principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental stress, Myogenic activation and Cold pressure test in people with Endothelial Function, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 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 1 Apr 2015. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in FMD in response to sympathetic activation (time frame: Change in FMD before versus 1 Minute after begin of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.