Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System (PAN)
|ClinicalTrials.gov Identifier: NCT01713374|
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : April 1, 2015
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 or disease||Intervention/treatment|
|Endothelial Function||Procedure: Mental stress Other: no intervention Procedure: Myogenic activation Procedure: Cold pressure test|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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.|
|Study Start Date :||October 2012|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2014|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713374
|University Medical Center Mainz|
|Mainz, Rheinland Pfalz, Germany, 55131|
|Principal Investigator:||Tommaso Gori, MD PhD||University Medical Center Mainz|