Autonomic Manifestations of Testosterone Deficiency in Men
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|ClinicalTrials.gov Identifier: NCT02715713|
Recruitment Status : Withdrawn (Principal Investigator left the institution in August, 2016;)
First Posted : March 22, 2016
Last Update Posted : October 18, 2016
|Condition or disease|
|Autonomic Neuropathy Male Hypogonadism|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Autonomic Manifestations of Testosterone Deficiency in Men|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
testosterone deficiency group
Men between the ages of 40 to 80-years-old with testosterone deficiency
prostate cancer group
Men between the ages of 40 to 80-years-old with prostate cancer that will result in testosterone deficiency due to surgical or pharmacological castration.
- Number of patients with testosterone deficiency who will have abnormal autonomic function test (abnormal heart rate response to deep breathing, abnormal Valsalva ratio, and abnormal tilt table i.e. orthostatic hypotension). [ Time Frame: 24 months ]
- Number of patients with testosterone deficiency and abnormal autonomic function test who will have such abnormalities corrected if they receive testosterone replacement therapy as part of standard of care. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715713
|United States, Texas|
|Texas Tech University Health Sciences Center|
|Lubbock, Texas, United States, 79430|
|Principal Investigator:||Ahmed M Eldokla, MD||Texas Tech Universty Health Science Center|