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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01713374
First Posted: October 24, 2012
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tommaso Gori, Johannes Gutenberg University Mainz
  Purpose

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.


Condition Intervention
Endothelial Function Procedure: Mental stress Other: no intervention Procedure: Myogenic activation Procedure: Cold pressure test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.

Further study details as provided by Tommaso Gori, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in FMC during sympathetic activation [ Time Frame: Change in FMC before versus 1 minute after begin of each intervention ]
    Change in Flow-mediated constriction induced by each of the interventions.


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.
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
A hand will be placed in ice-cold water.
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
Subjects will be asked to perform complex mathematic operations at a very fast pace
Active Comparator: Control
Control visit - no intervention performed - subjects will undergo endothelial function measurement twice at a distance of 45 minutes
Other: no intervention
control visit

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • any active disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713374


Locations
Germany
University Medical Center Mainz
Mainz, Rheinland Pfalz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Tommaso Gori, MD PhD University Medical Center Mainz
  More Information

Responsible Party: Tommaso Gori, Professor, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01713374     History of Changes
Other Study ID Numbers: PAN-1
First Submitted: October 18, 2012
First Posted: October 24, 2012
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Tommaso Gori, Johannes Gutenberg University Mainz:
endothelial function
sympathetic nervous system