Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)

Completed · Phase 4

Conditions studied: Hypogonadism, Severe Obesity

In brief

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.

Key facts

Study ID

NCT02959853

Run by

Baylor College of Medicine

People needed

23

Starts

2016-06-01

Expected to finish

2018-12-20

Last updated by the study team

2020-01-30

Who can join

Age: 35 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• severely obese (BMI >= 35) male veterans with hypogonadotropic hypogonadism defined as low total testosterone (lower than 300 ng/dl) between 35-65 years of age
• Luteinizing hormone (LH) lower than 9 U/L
• estradiol above 40 pmol/l
• normal Free T4 (FT4), Thyroid Stimulating Hormone (TSH), prolactin, cortisol, Adrenocorticotropic hormone (ACTH), and Insulin-like growth factor-1 (IGF-1) levels.
• Subjects must be ambulatory, willing and able to provide written informed consent

You may not qualify if…

• clinical or biochemical evidence of pituitary or hypothalamic disease
• any ongoing illness that, in the opinion of the investigator, could prevent the subject from completing study
• any med known to affect gonadal hormones, steroid hormone-binding globulin or bone metabolism, e.g.,
• androgens
• estrogens
• glucocorticoids
• phenytoin
• bisphosphonates
• any medication known to interfere with anastrozole metabolism, e.g. tamoxifen or estrogens
• diseases known to interfere with bone metabolism as
• osteoporosis
• hyperparathyroidism
• untreated hyperthyroidism
• osteomalacia
• chronic liver disease
• renal failure
• hypercortisolism
• malabsorption
• immobilization
• patients with a Total T score lower than -2.0 at Lumbar Spine or Left Femur.
• patients with symptomatic prostate disease, prostate carcinoma, or elevated serum Prostate-specific antigen (PSA) >4 ng/ml or >3 for subjects with a family history of prostate cancer among 1st degree relatives needs urologic evaluation before admission into study
• hematocrit greater than 50%
• untreated severe obstructive sleep apnea
• severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS) above 19
• documented heart failure

Where it is running

• Michael E. DeBakey Veterans Affairs Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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