Obesity, Morbid
Conditions
Keywords
hypercortisolism, hypogonadism
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.
Interventions
None listed
Sponsors
Ministry of Health, Italy
Istituto Auxologico Italiano
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association of androgen milieu with the severity of obesity | 2024 | 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 obesity | 2024 | 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 obesity | 2024 | Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of hypogonadism in morbid obesity | 2024 | To evaluate the prevalence of hypogonadism in patients with severe obesity using EMAS criteria |
| Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing | 2025 | Compare the enrichment in rare variants in genes associated with hypercortisolism in obese patients unresponsive to Nugent testing, compared to the general population |
| Prevalence of patients with morbid obesity unresponsive to overnight suppression test | 2024 | To evaluate the prevalence of patients with severe obesity positive to Nugent testing |
| Enrichment in rare HH variants in obese patients with central hypogonadism | 2025 | Compare the enrichment in rare variants for HH-associated genes in obese patients with hypogonadotropic hypogonadism, compared to the general population |
Countries
Italy
Contacts
Primary ContactBiagio Cangiano, MD
Outcome results
None listed