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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Endothelial Function

Treatments: Procedure: Mental stress; Other: no intervention; Procedure: Cold pressure test; Procedure: Myogenic activation

Study type: Interventional

Funder types: Other

Identifiers

NCT01713374

PAN-1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• any active disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Myogenic activation

Active Comparator group

Description:

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

Treatment:

Procedure: Myogenic activation

Cold pressure test

Active Comparator group

Description:

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

Treatment:

Procedure: Cold pressure test

mental stress

Active Comparator group

Description:

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

Treatment:

Procedure: Mental stress

Control

Active Comparator group

Description:

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

Treatment:

Other: no intervention