Study of the Steroid Hormone Milieu in Obese Patients (MiSterO)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Obesity, Morbid

Study type: Observational

Funder types: Other

Identifiers

NCT06341699

05C308

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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