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The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension

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ClinicalTrials.gov Identifier: NCT01938911
Recruitment Status : Terminated (PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.)
First Posted : September 10, 2013
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Syntocinon-Spray Drug: Placebo of syntocinon Behavioral: Social support Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Hypertensives with oxytocin and social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)

Behavioral: Social support
Social support from the best friend

Experimental: Hypertensives with oxytocin without social support
80 normotensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)

Experimental: Hypertensives without oxytocin with social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration

Behavioral: Social support
Social support from the best friend

Placebo Comparator: Hypertensives without oxytocin or social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration

Experimental: Normotensives with oxytocin and social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)

Behavioral: Social support
Social support from the best friend

Experimental: Normotensives with oxytocin without social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Syntocinon-Spray
Intranasal oxytocin (24 IU)

Experimental: Normotensives without oxytocin with social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration

Behavioral: Social support
Social support from the best friend

Placebo Comparator: Normotensives without oxytocin or social support
80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.
Drug: Placebo of syntocinon
Intranasal administration




Primary Outcome Measures :
  1. Change in lipids from baseline [ Time Frame: At 110 minutes ]

Secondary Outcome Measures :
  1. Change in lipids from baseline [ Time Frame: At 45, 80, 120, 130, and 170 minutes ]
  2. Change in catecholamines from baseline [ Time Frame: At 45, 80, 110, 120, 130, 140, 155, and 170 minutes ]
  3. Change in cortisol from baseline [ Time Frame: At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes ]
  4. Change in cytokine level from baseline [ Time Frame: At 45, 80, 110, 120, 200, and 230 minutes ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

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): NCT01938911


Locations
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Switzerland
Department of Psychology, University of Bern
Bern, Switzerland, 3012
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Study Chair: Petra Wirtz, Prof. Dr. University of Konstanz

Additional Information:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01938911     History of Changes
Other Study ID Numbers: 215/10
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by University Hospital Inselspital, Berne:
Trier social stress test
Oxytocin
Hypertension

Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs