Observational Study of Steroid Hormones in Severely Obese Men Examining Hormone Effects on Bone, Lipoproteins, and Cardiovascular Risk

What this Trial Is About

This observational study focuses on male patients aged 18 to 80 years with severe obesity. It aims to evaluate the secretion levels of cortisol and testosterone and the sensitivity of their receptors. Researchers want to understand if these hormonal factors are linked to changes in bone metabolism, lipoprotein concentration and function, and the severity or complications of obesity. The study also investigates whether these hormone patterns can predict cardiovascular disease in obese patients. Participants will undergo assessments including questionnaires about mood and symptoms, collection of medical history and clinical data related to obesity complications, and measurements of body mass index BMI. Blood samples will be collected and analyzed at a central laboratory to study steroid hormones, bone metabolism, lipoprotein function, genetics, and receptor sensitivity. Cortisol suppression will be tested using a 1 mg dexamethasone test. During the study, data collected at enrollment and laboratory analyses will help measure the association of androgen and cortisol hormone levels with obesity severity and cardiovascular risk. The research team will also examine the prevalence of hypogonadism and resistance to cortisol suppression in the participants. The study is led by Istituto Auxologico Italiano and runs through June 2026.

Study of the Steroid Hormone Milieu in Obese Patients