Cortisol Secretion, Sensitivity and Activity and Hypertension

NCT ID: NCT05766085

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercortisolism Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hypertension

Those patients suffering from arterial hypertension

Dexamethasone suppression test

Intervention Type DIAGNOSTIC_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

Dexamethasone suppression test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carmen Aresta, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano IRCCS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Auxologico Italiano IRCCS

Milan, MI, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carmen Aresta, MD

Role: CONTACT

+3902619112506

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carmen Aresta, MD

Role: primary

+3902619112506

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05C921

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hormonal Influences on Diuresis
NCT04891926 COMPLETED NA