Clinical trial NCT01938911: The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
Official title: The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Hypertension
Keywords: Trier social stress test
Oxytocin
Hypertension
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2013-09-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To test a psychopharmacological intervention strategy which may provide new insights into the mechanisms underlying the physiological hyperreactivity to stress observed in hypertension, we plan to test the effects of the neuropeptide oxytocin and social support on the neurobiological and psychological responsiveness to social stress. The study population for this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free men. We expect exogenous oxytocin administration to enable hypertensives to effectively take advantage of the provided social support. Thereby, oxytocin may enhance the effect of social support on reducing the previously observed physiological hyperreactivity to stress in essential hypertensives.

Detailed description: Background

Data on psychobiological stress reactivity in essential hypertension demonstrated physiological hyperreactivity to acute psychosocial stress in hypertensives as compared to normotensive controls in terms of sympathetic nervous system and hypothalamus-pituitary-adrenal axis activity, blood lipids, and coagulation activity. Moreover, we found lower perceived social support in hypertensives as compared to normotensives, with the highest physiological stress responses in hypertensives with low perceived social support.. In addition, the collaborating group of Prof. Heinrichs demonstrated that OT and social support interact to reduce neuroendocrine responses to stress in normotensive individuals. Given these findings and given the aforementioned hypothesized role for OT in physiological stress reactivity, particularly in hypertension, it seems promising to investigate the combined effects of OT and social support provision on physiological stress reactivity in essential hypertensives as compared to normotensives.

Objective

The proposed project will provide new information on neuroendocrine mechanisms underlying the observed physiological hyperreactivity to stress in essential hypertension. Moreover, stress reactivity of intermediate biological risk factors has not yet been investigated in experiments studying the effects of the acutely provided social support, either in healthy individuals or in hypertensives. The results of this project may provide important information for the development of effective interdisciplinary prevention and intervention strategies for essential hypertension

Methods

The methodological approach of social stress induction by the TSST used in our previous hypertension study will be translated to the planned project and we will repeatedly collect blood and saliva samples to measure neuroendocrine reactivity in terms of cortisol, epinephrine, and norepinephrine, as well as continuously measuring of heart rate and blood pressure. Blood pressure will be measured at each sampling timepoint as well as twice during the TSST (during the speech and during mental arithmetics). As our recent findings suggest strong associations between social support and heightened coagulation activity in healthy subjects before and after social stress, and as we found higher lipid and coagulation reactivity to psychosocial stress in hypertensives with catecholamine stress changes predicting elevated lipid stress reactivity, we plan to additionally measure biological risk factors for CHD.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80 years
* sufficient knowledge of German language in reading and understanding
* medication-free
* non-smoking
* systolic blood pressure ≥ 140 \< 180 mmHg and/or diastolic blood pressure ≥ 90 \< 110 mmHg for the hypertension group
* systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg for the normotensive control
* written informed consent

Exclusion Criteria

* any alcohol, caffeine, and theine consumption 24 hours before the experiment
* regular strenuous exercise
* alcohol and illicit drug abuse
* liver and renal diseases
* chronic obstructive pulmonary disease
* allergies and atopic diathesis
* rheumatic diseases
* HIV
* cancer
* psychiatric and neurological diseases
* current infectious diseases

Primary outcomes:
measure: Change in lipids from baseline
timeFrame: At 110 minutes
Secondary outcomes:
measure: Change in lipids from baseline
timeFrame: At 45, 80, 120, 130, and 170 minutes
measure: Change in catecholamines from baseline
timeFrame: At 45, 80, 110, 120, 130, 140, 155, and 170 minutes
measure: Change in cortisol from baseline
timeFrame: At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes
measure: Change in cytokine level from baseline
timeFrame: At 45, 80, 110, 120, 200, and 230 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Psychology, University of Bern
Study officials:
affiliation: University of Konstanz
name: Petra Wirtz, Prof. Dr.
role: STUDY_CHAIR
References: