Male Hypogonadism Clinical Trial
Official title:
Autonomic Manifestations of Testosterone Deficiency in Men
The primary goal of this pilot study is to investigate the association between testosterone deficiency and the presence of abnormalities in the function of the autonomic nervous system. If such association exists, then we will investigate the effect of testosterone replacement therapy on correcting these abnormalities.
The investigators will recruit 40 men between the ages of 40 to 80-years-old with low
testosterone. Participants will be selected among those males referred to the Texas Tech
University Health Sciences Center's (TTUHSC's) Internal Medicine Endocrinology Division
outpatient clinic for the study and management of testosterone deficiency and to the TTUHSC
Urology Department for diagnosis and management of prostate cancer that will result in
testosterone deficiency due to surgical or pharmacological castration.
After recruitment, patients will have an initial standard clinical visit where aspects such
as fatigue and anxiety will be investigated, followed by a full battery of autonomic testing
(tilt table, heart rate response to deep breathing, Valsalva, and the Quantitative Sudomotor
Axon Reflex Test (QSART).
Those patients with an initial diagnosis of testosterone deficiency will be initiated on
testosterone replacement (intramuscular or skin routes) as standard of care, followed by a
second visit in three (3) months--after normalization of serum testosterone levels--to
evaluate changes in anxiety and fatigue level, and to repeat the cardiovascular autonomic
function test.
Those patients with primary diagnosis of prostate cancer and normal serum testosterone
levels will be evaluated a second time after confirmation of low testosterone, as described
above. Standard questionnaires will be used to evaluate fatigue and anxiety. The autonomic
testing of the heart will include tilt table (tilt the patient 70 degree by special designed
table) and heart rate response to deep breathing, and Valsalva maneuver. Descriptive
statistics will be compared between before and after treatment using different statistical
methods.
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Observational Model: Case Control, Time Perspective: Prospective
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