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CompletedNCT01713374PANUpdated Apr 1, 2015

Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System

An interventional study of Mental stress and no intervention in Endothelial Function, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-01.

Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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). 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.

02

Conditions studied

  • Endothelial Function

Keywords

  • endothelial function
  • sympathetic nervous system
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In context

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ECG.

Exclusion criteria

Exclusion Criteria:

  • any active disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Myogenic activation

    Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of myogenic activation

    Procedure: Myogenic activation

  • Active comparator
    Cold pressure test

    Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of cold pressure test

    Procedure: Cold pressure test

  • Active comparator
    mental stress

    Subjects will undergo endothelial function assessment at rest and, after a 45 minutes pause, 1 minute after begin of mental stress

    Procedure: Mental stress

  • Active comparator
    Control

    Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes

    Other: no intervention

Interventions

  • ProcedureMental stress

    Subjects will be asked to perform complex mathematic operations at a very fast pace

  • Otherno intervention

    control visit

  • ProcedureMyogenic activation

    A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.

  • ProcedureCold pressure test

    A hand will be placed in ice-cold water.

06

What researchers measure

Primary outcomes

  1. Change in FMD in response to sympathetic activation

    Flow-mediated dilation will be measured at rest and during each of the interventions.

    Time frame: 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.

    Time frame: Change in FMC before versus 1 minute after begin of each intervention

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Study locations

1 site
  • University Medical Center Mainz
    Mainz, Rheinland Pfalz 55131, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01713374
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Tommaso Gori (Professor, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Oct 24, 2012
Start date
Oct 2012
Primary completion
Mar 2013
Completion
Mar 2014
Last update
Apr 1, 2015

Study contacts

Tommaso Gori, MD PhD
principal investigator · University Medical Center Mainz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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