Cortisol Secretion, Sensitivity and Activity and Hypertension

Arterial Hypertension Clinical Trial

— PRECOR  

Official title:

Cortisol Secretion, Sensitivity and Activity and Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766085
• Other study ID #: 05C921
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Carmen Aresta, MD
• Phone: +3902619112506
• Email: c.aresta[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Arterial Hypertension
• Cushing Syndrome
• Hypercortisolism
• Hypersensitivity
• Hypertension

Intervention

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)

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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