Clinical trial NCT06341699: Study of the Steroid Hormone Milieu in Obese Patients
Official title: Studio Del Milieu Steroideo in Pazienti Obesi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: hypercortisolism
hypogonadism
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2024-04-02
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected with severe obesity

Brief summary: The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.

It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.

Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.

Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.


Eligibility criteria: Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause PCR \>10 mg/dL
* use of corticosteroids at the time of enrollment
* the patient's poor understanding of spoken and written Italian
* patients suffering from primary pathologies of the testicle, known at enrollment
* patients suffering from hypothalamic-pituitary or adrenal pathologies already known at the time of enrollment

Primary outcomes:
measure: Association of androgen milieu with the severity of obesity
timeFrame: 2024
measure: Association of cortisol milieu with the severity of obesity
timeFrame: 2024
measure: Algorithm fo CV risk in obesity
timeFrame: 2024
Secondary outcomes:
measure: Prevalence of hypogonadism in morbid obesity
timeFrame: 2024
measure: Prevalence of patients with morbid obesity unresponsive to overnight suppression test
timeFrame: 2024
measure: Enrichment in rare HH variants in obese patients with central hypogonadism
timeFrame: 2025
measure: Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing
timeFrame: 2025
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo
state: Verbania
Study officials:
References: