Study of the Steroid Hormone Milieu in Obese Patients
Recruiting · NCT06341699 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituto Auxologico Italiano
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
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
Where it is running
1 location listed.
- Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo - Oggebbio, Verbania, Italy