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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Recruitment Status : Withdrawn (Principal Investigator left the institution in August, 2016;)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
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief Summary:
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.

Condition or disease
Autonomic Neuropathy Male Hypogonadism

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Two groups will be recruited with 20 men in each group:

Group 1 will include 20 men between the ages of 40 to 80-years-old with symptoms and biochemical parameters of low testosterone.

Group 2 will include 20 men between the ages of 40 to 80-years-old with prostate cancer and normal serum testosterone that will be treated with surgical or pharmacological castration, as following standard of care at Urology Division, resulting in testosterone deficiency.

Criteria

Inclusion Criteria for first group:

  1. Patients with testosterone deficiency (total testosterone< 277 ng/dL [9.6 nmol/L]) measured between 7-10 am, and with one or more symptoms and signs suggestive of androgen deficiency as mainly determined by history.

    • Reduced sexual desire (libido)
    • Decreased spontaneous erections
    • Breast discomfort, gynecomastia
    • Loss of body (axillary and pubic) hair - reduced shaving
    • Very small (<5ml) or shrinking testes
    • Height loss
    • Low trauma fracture
    • Low bone mineral density
    • Hot flushes
    • Sweats
    • Decreased energy
    • Decreased motivation
    • Decreased initiative
    • Decreased self confidence
    • Feeling sad or blue
    • Depressed mood
    • Dysthymia
    • Poor concentration
    • Poor memory
    • Sleep disturbance
    • Increased sleepiness
  2. Age 40 to 80 years

Inclusion Criteria for second group:

  1. Patients who underwent chemical or surgical castration for prostatic cancer who are going to receive androgen deprivation therapy.
  2. Age 40 to 80 years

Exclusion Criteria (both groups):

1. Patients with history or current diagnosis of:

  • Atrial fibrillation.
  • Cardiac arrythmia
  • Pacemaker placement.
  • Myocardial infarction < 3 months
  • Uncontrolled diabetes mellitus with hemoglobin A1c > 8.5% in the last 6 months.
  • Diabetes mellitus with autonomic neuropathy
  • Breast cancer
  • Heart failure with left ventricular ejection fraction below 35%.
  • Severe sleep apnea.
  • Recent eye surgery (< 3 months)
  • Recent ischemic stroke (< 3 months)
  • History of retinal detachment.
  • History of brain aneurysm.
  • Severe chronic obstructive pulmonary disease (COPD) on oxygen therapy.
  • Intraocular hemorrhage and lens dislocation.
  • Glaucoma.
  • Thyroid disease.
  • Not literate in English

Exclusion Criteria for patient who will receive testosterone treatment

  • Metastatic prostate cancer
  • Prostate-specific antigen (PSA) concentration >4.0 mcg/L,
  • Prostate-specific antigen (PSA) >3.0 mcg/L in high-risk men (African-Americans or men with first-degree relatives with prostate cancer). (Measured at clinic visit 1)
  • Polycythemia (hemoglobin level >18 g/dL, hematocrit > 52%) (measured at clinic visit 1)
  • Severe acne.
  • History of venous or arterial thrombosis.
  • Persons not literate in English

Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Ahmed M Eldokla, MD Texas Tech Universty Health Science Center
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02715713    
Other Study ID Numbers: L16-059
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Texas Tech University Health Sciences Center:
Autonomic neuropathy, Testosterone Deficiency
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases