Clinical trial NCT05766085: Cortisol Secretion, Sensitivity and Activity and Hypertension
Official title: Cortisol Secretion, Sensitivity and Activity and Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypercortisolism
Arterial Hypertension
Keywords: hypertension
hidden hypercortisolism
hypercortisolism
cortisol sensitivity
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 290
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertension group: patients with hypertension referred to the cardiology clinics of Istituto Auxologico Italiano, Milan No hypertension group: patients without hypertension referred to endocrinology clinics of Istituto Auxologico Italiano for other diseases (e.g. euthyroid nodular goiter or chronic lymphocytic euthyroid thyroiditis)

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


Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence of hidden hypercortisolism (HidHyCo)
timeFrame: At baseline
Secondary outcomes:
measure: Evaluation of organ damage
timeFrame: At baseline
measure: Evaluation of oxidative stress level
timeFrame: At baseline
measure: Evaluation of cortisol secretion degree
timeFrame: At baseline
measure: Evaluation of glucocorticoid sensitivity
timeFrame: At baseline
measure: Evaluation of glucocorticoid peripheral activity
timeFrame: At baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: MI
Study officials:
affiliation: Istituto Auxologico Italiano IRCCS
name: Carmen Aresta, MD
role: PRINCIPAL_INVESTIGATOR
References: