Clinical trial

Study of the Steroid Hormone Milieu in Obese Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT06341699

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexMale

Healthy volunteersNot accepted

ConditionObesity, Morbid

Full registry 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Association of androgen milieu with the severity of obesity2024

Evaluate the association of hypogonadism and/or androgen receptor polymorphisms that reduce sensitivity to androgens with: patients' BMI; comorbidities of obesity, and bone metabolism

Association of cortisol milieu with the severity of obesity2024

Evaluate the association of hypercortisolism and/or glucocorticoid receptor polymorphisms that increase sensitivity to cortisol with: patients' BMI; comorbidities of obesity, and bone metabolism

Algorithm fo CV risk in obesity2024

Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo🇮🇹 Oggebbio, Verbania, Italy

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Biagio Cangiano, MDContact

Email · Call 3343177491

Massimo Scacchi, ProfessorContact