HypercortisolismPRECORNCT05766085
Cortisol Secretion, Sensitivity and Activity and Hypertension
An observational study of Hypercortisolism and Arterial Hypertension, run by Istituto Auxologico Italiano at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypercortisolism, Arterial Hypertension
- What is being tested?
- Dexamethasone suppression test
- How many people
- 290 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Hypertension group: arterial hypertension
- No hypertension group: absence of arterial hypertension
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, MI, 20145
Carmen Aresta, MD, +3902619112506, c.aresta@auxologico.it
About this study
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
- Conditions
- Hypercortisolism, Arterial Hypertension
- Being tested
- Dexamethasone suppression test
- Keywords
- hypertension, hidden hypercortisolism, hypercortisolism, cortisol sensitivity
- Medical subject headings
- Cushing Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone suppression testDiagnostic test
Determination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST)
| Study group | Role | What they receive |
|---|---|---|
| hypertension | Those patients suffering from arterial hypertension Receives: Diagnostic Test: Dexamethasone suppression test | |
| no hypertension | Those patients without arterial hypertension Receives: Diagnostic Test: Dexamethasone suppression test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (5)
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
Measured: At baseline
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
Measured: At baseline
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
Measured: At baseline
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
Measured: At baseline
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Apr 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercortisolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Aresta, MD, Principal investigator, Istituto Auxologico Italiano IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766085
- Sponsor's protocol ID
- 05C921
- Acronym
- PRECOR
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol Secretion, Sensitivity and Activity and Hypertension
- ClinicalTrials.gov ID
- NCT05766085
- Acronym / sponsor ID
- PRECOR / 05C921
- Conditions
- Hypercortisolism, Arterial Hypertension
- Keywords
- hypertension, hidden hypercortisolism, hypercortisolism, cortisol sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertension | – | Diagnostic Test: Dexamethasone suppression testThose patients suffering from arterial hypertension |
| no hypertension | – | Diagnostic Test: Dexamethasone suppression testThose patients without arterial hypertension |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Hypertension group: arterial hypertension
- No hypertension group: absence of arterial hypertension
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone suppression testDetermination of cortisol levels at 9.00 am after taking 1 mg of dexamethasone the previous evening at 11.00 pm (1mg DST) | Diagnostic test | hypertension, no hypertension |
Primary outcome
Prevalence of hidden hypercortisolism (HidHyCo)
Time frame: At baseline
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.
5 secondary outcomes
Evaluation of organ damage
Time frame: At baseline
Evaluation of oxidative stress level
Time frame: At baseline
Evaluation of cortisol secretion degree
Time frame: At baseline
Evaluation of glucocorticoid sensitivity
Time frame: At baseline
Evaluation of glucocorticoid peripheral activity
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Aresta, MD principal investigator
Istituto Auxologico Italiano IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercortisolism and Arterial Hypertension, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Aresta, MD (+3902619112506, c.aresta@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hidden hypercortisolism (HidHyCo) (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.