Ricerc@Sapienza

Body fat distribution predicts the development of obesity-related complications in patients with obesity, and ectopic fat accumulation, namely visceral adipose tissue and epicardial fat (EF), is associated with higher cardiovascular risk. Functional hypogonadism (FG) represents either cause and consequence of obesity, with the two conditions often coexistent; Testosterone replacement therapy (TRT) in patients with obesity and classical hypogonadism predisposes to better outcomes in terms of body weight reduction/distribution and cardiometabolic status. However, in clinical routine patients suffering with obesity and concomitant FG are often left untreated. Our hypothesis is that male individuals with obesity and FG may derive greater benefit from TRT in association with nutritional intervention (NI) in terms of body fat mass decrease and EF reduction compared to controls undergoing NI alone. Our aim is to investigate the impact of TRT in association with NI on body fat mass and distribution, cardiac ultrasound-derived EF thickness (EFT), metabolic status in patients with obesity and FG. In this open-label randomized pilot study, 40 male patients with obesity and FG will be randomized in 2 groups. 20 patients enrolled in the NI-group will follow a hypocaloric diet, whereas 20 patients enrolled in the TRT+NI group will follow a TRT in addition to the same dietary intervention for 6 months. At the baseline and at the end of the study, Cardiac Ultrasound Examination-derived EFT will be calculated, body composition through dual-energy-X-ray absorptiometry will be performed and blood samples for hormonal and metabolic parameters will be collected. If our hypothesis will be confirmed, we expect patients in the TRT+NI group to show greater body weight reduction, body fat composition amelioration, EFT reduction compared to control. Considering the high prevalence of both conditions, this knowledge would help clinicians achieve a more personalized management of obesity.