Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
Status:
Completed
Trial end date:
2018-12-20
Target enrollment:
Participant gender:
Summary
After the age of 40, there is a gradual decline in the production of testosterone. Among
obese men, the decline in testosterone levels is exacerbated by the suppression of the
hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase
enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in
turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition
of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle
stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in
hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI
in certain populations, such as women with breast cancer, HH obese men present high levels of
circulating estrogens that could potentially prevent them from bone loss, estradiol being the
main regulator of the male skeleton. This study is designed to determine if aromatase
inhibitors in combination with weight loss, compared to weight loss alone, will have a
positive effect on muscle strength, symptoms of hypogonadism, and body composition without
negatively impacting bone mineral density and bone quality. Results from this study will help
determine if certain groups of obese patients would benefit from therapy with aromatase
inhibitors.