Cortisol Secretion, Sensitivity and Activity and Hypertension

Study Overview
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Brief Summary
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The goal of this observational study is to evaluate, between patients with arterial hypertension and non hypertensive control group, the prevalence of hidden hypercortisolism the relationship between organ damage and oxidative stress level, cortisol secretion degree, sensitivity and peripheral activity

Official Title
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Cortisol Secretion, Sensitivity and Activity and Hypertension

Conditions
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Hypercortisolism, Arterial Hypertension

Intervention / Treatment
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* Diagnostic Test: Dexamethasone suppression test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension group: arterial hypertension No hypertension group: absence of arterial hypertension Exclusion Criteria: body mass index (BMI) >30 kg/m2 active smoking (>20 cigarettes/day) pregnancy/lactation hypertension associated with family history of hypertension and cerebrovascular events before 40 years of age sleep apnea hypertension appearance in pre-pubertal age hypokalemia hypertension in the setting of an incidental adrenal mass classic signs and symptoms of hypercortisolism (lunar facies, striae, hypertrichosis, skin atrophy, hump) proven endocrine hypertension (pheochromocytoma, hyperaldosteronism, hyperparathyroidism, acromegaly, hyperthyroidism) renovascular hypertension diseases or conditions associated with increased activity of the hypothalamic-pituitary- adrenal axis and/or oxidative stress, such as type 2 diabetes, rheumatoid arthritis, severe rheumatic/autoimmune diseases, severe hematological diseases, alcoholism, depressive syndrome, chronic renal failure (GFR <45 ml/min), severe hypovitaminosis D (25OHvitaminD <10 ng/dL) therapies that interfere with the activity of the HPA axis (i.e. glucocorticoids, antidepressants).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertension<br>Those patients suffering from arterial hypertension | Diagnostic Test: Dexamethasone suppression test<br>* Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)<br>|
| no hypertension<br>Those patients without arterial hypertension | Diagnostic Test: Dexamethasone suppression test<br>* Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hidden hypercortisolism (HidHyCo) | The presence of HidHyCo will be evaluated through the determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mgDST). In case of 1mgDST >1.8 µg/dL the patient will repeat the test and, if the result is confirmed, the patients is considered to have HidHyCo. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of organ damage | Organ damage will be assessed by performing echocardiography, carotid echo-doppler (arterial stiffness) and microalbuminuria evaluation, which assess hypertensive heart disease, macro-angiopathy and hypertensive nephropathy, respectively | At baseline | 
| Evaluation of oxidative stress level | The determination of the degree of oxidative stress will be carried out in all patients by evaluating the enzymatic activity of dipeptidyl peptidase 3 (DPP3) in the serum | At baseline | 
| Evaluation of cortisol secretion degree | The cortisol secretion will be evaluated by measuring morning plasma ACTH and serum cortisol, 24-hour urinary free cortisol, serum cortisol at 09:00 after the administration of 1 mg dexamethasone at 11 PM on the previous day | At baseline | 
| Evaluation of glucocorticoid sensitivity | In all subjects, genotyping of the N363S, BclI, ER22/23EK polymorphisms of the GR gene and of the polymorphisms will be performed | At baseline | 
| Evaluation of glucocorticoid peripheral activity | Urinary free cortisol and urinary free cortisone will be measured in all subjects; their ratio will be used as measure of glucocorticoid peripheral activity | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, hidden hypercortisolism, hypercortisolism, cortisol sensitivity