Skip to content

Cortisol Secretion, Sensitivity and Activity and Hypertension

Cortisol Secretion, Sensitivity and Activity and Hypertension

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05766085
Acronym
PRECOR
Enrollment
290
Registered
2023-03-13
Start date
2021-04-15
Completion date
2024-02-01
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Hypercortisolism

Keywords

hypertension, hidden hypercortisolism, hypercortisolism, cortisol sensitivity

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

Interventions

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of hidden hypercortisolism (HidHyCo)At baselineThe 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

MeasureTime frameDescription
Evaluation of organ damageAt baselineOrgan 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 levelAt baselineThe 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 degreeAt baselineThe 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 sensitivityAt baselineIn 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 activityAt baselineUrinary free cortisol and urinary free cortisone will be measured in all subjects; their ratio will be used as measure of glucocorticoid peripheral activity

Countries

Italy

Contacts

Primary ContactCarmen Aresta, MD
c.aresta@auxologico.it+3902619112506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026