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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Tommaso Gori, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01713374
First received: October 18, 2012
Last updated: March 16, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in Flow-mediated constriction induced by each of the interventions.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated 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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713374

Contacts
Contact: Tommaso Gori, MD PhD Prof +496131172829 tommaso.gori@unimedizin-mainz.de

Locations
Germany
University Medical Center Mainz Recruiting
Mainz, Rheinland Pfalz, Germany, 55131
Contact: Tommaso Gori, MD PhD    +496131172829    tommaso.gori@unimedizin-mainz.de   
Principal Investigator: Markus Vosseler, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Tommaso Gori, MD PhD University Medical Center Mainz
  More Information

No publications provided

Responsible Party: Tommaso Gori, Professor, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01713374     History of Changes
Other Study ID Numbers: PAN-1
Study First Received: October 18, 2012
Last Updated: March 16, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 21, 2014