PRECOR: Cortisol Secretion, Sensitivity and Activity and Hypertension

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766085

Collaborator

(none)

290

Enrollment

Location

33.6

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypercortisolism Arterial Hypertension	Diagnostic Test: Dexamethasone suppression test

Study Design

Study Type:

Observational

Anticipated Enrollment :

290 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Cortisol Secretion, Sensitivity and Activity and Hypertension

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

hypertension

Those patients suffering from arterial hypertension

Diagnostic Test: Dexamethasone suppression test

Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)

no hypertension

Those patients without arterial hypertension

Diagnostic Test: Dexamethasone suppression test

Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)

Outcome Measures

Primary Outcome Measures

Prevalence of hidden hypercortisolism (HidHyCo) [At baseline]
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.

Secondary Outcome Measures

Evaluation of organ damage [At baseline]
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
Evaluation of oxidative stress level [At baseline]
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
Evaluation of cortisol secretion degree [At baseline]
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
Evaluation of glucocorticoid sensitivity [At baseline]
In all subjects, genotyping of the N363S, BclI, ER22/23EK polymorphisms of the GR gene and of the polymorphisms will be performed
Evaluation of glucocorticoid peripheral activity [At baseline]
Urinary free cortisol and urinary free cortisone will be measured in all subjects; their ratio will be used as measure of glucocorticoid peripheral activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).