ClinicalTrials.gg
Status unknownNCT05766085PRECORUpdated Mar 13, 2023

Cortisol Secretion, Sensitivity and Activity and Hypertension

An observational study in Hypercortisolism and Arterial Hypertension, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Istituto Auxologico Italiano · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
290
Ages
30 Years to 70 Years
Sex
All
01

Study 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
02

Conditions studied

  • Hypercortisolism
  • Arterial Hypertension

Keywords

  • hypertension
  • hidden hypercortisolism
  • hypercortisolism
  • cortisol sensitivity
03

In context

Cushing Syndrome

130 studies on the registry are indexed under Cushing Syndrome; 40 are open to participants now.

This study's planned enrollment of 290 is above the median of 121 across 67 observational studies indexed under Cushing Syndrome.

Browse Cushing Syndrome studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hypertension group: arterial hypertension
  • No hypertension group: absence of arterial hypertension

Exclusion criteria

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).
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
290 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • hypertension

    Those patients suffering from arterial hypertension

    Diagnostic Test: Dexamethasone suppression test

  • no hypertension

    Those patients without arterial hypertension

    Diagnostic Test: Dexamethasone suppression test

Interventions

  • Diagnostic testDexamethasone 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline

Secondary outcomes

  1. 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

    Time frame: At baseline

  2. 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

    Time frame: At baseline

  3. 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

    Time frame: At baseline

  4. 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

    Time frame: At baseline

  5. 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

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • Istituto Auxologico Italiano IRCCS
    Milan, MI 20145, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05766085
Responsible party
Sponsor
First posted
Mar 13, 2023
Start date
Apr 15, 2021
Primary completion
Feb 1, 2024 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Mar 13, 2023

Study contacts

Carmen Aresta, MD
Contact
c.aresta@auxologico.it
+3902619112506
Carmen Aresta, MD
principal investigator · Istituto Auxologico Italiano IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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