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PI moved away from Bern; lack of personnel in Bern to conduct the study within a reasonable time frame.
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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertensives with oxytocin and social support | Experimental | 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. |
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| Hypertensives with oxytocin without social support | Experimental | 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. |
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| Hypertensives without oxytocin with social support | Experimental | 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. |
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| Hypertensives without oxytocin or social support | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syntocinon-Spray | Drug | Intranasal oxytocin (24 IU) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in lipids from baseline | At 110 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipids from baseline | At 45, 80, 120, 130, and 170 minutes | |
| Change in catecholamines from baseline | At 45, 80, 110, 120, 130, 140, 155, and 170 minutes | |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Petra Wirtz, Prof. Dr. | University of Konstanz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, University of Bern | Bern | 3012 | Switzerland |
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| Label | URL |
|---|---|
| Clinical Trial of effects of social support and oxytocin on physiological stress reactivity in essential hypertension | View source |
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| Normotensives with oxytocin and social support | Experimental | 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. |
|
| Normotensives with oxytocin without social support | Experimental | 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. |
|
| Normotensives without oxytocin with social support | Experimental | 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. |
|
| Normotensives without oxytocin or social support | Placebo Comparator | 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. |
|
| Placebo of syntocinon | Drug | Intranasal administration |
|
| Social support | Behavioral | Social support from the best friend |
|
| Change in cortisol from baseline |
| At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes |
| Change in cytokine level from baseline | At 45, 80, 110, 120, 200, and 230 minutes |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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