Autonomic NeuropathyNCT02715713
Autonomic Manifestations of Testosterone Deficiency in Men
An observational study of Autonomic Neuropathy and Male Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Autonomic Neuropathy, Male Hypogonadism
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
- Age 40 to 80 years
- Patients who underwent chemical or surgical castration for prostatic cancer who are going to receive androgen deprivation therapy.
- Age 40 to 80 years
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
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.
Read the 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.
- Conditions
- Autonomic Neuropathy, Male Hypogonadism
- Keywords
- Autonomic neuropathy, Testosterone Deficiency
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Secondary outcomes (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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Principal Investigator left the institution in August, 2016;
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Eldokla, MD, Principal investigator, Texas Tech Universty Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715713
- Sponsor's protocol ID
- L16-059
- Status last verified
- Oct 2016
- First submitted
- 17 Mar 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Manifestations of Testosterone Deficiency in Men
- ClinicalTrials.gov ID
- NCT02715713
- Acronym / sponsor ID
- L16-059
- Conditions
- Autonomic Neuropathy, Male Hypogonadism
- Keywords
- Autonomic neuropathy, Testosterone Deficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution in August, 2016;
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (25 listed)
- 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.
- Age 40 to 80 years
- Patients who underwent chemical or surgical castration for prostatic cancer who are going to receive androgen deprivation therapy.
- Age 40 to 80 years
Key exclusion criteria (27 listed)
- Atrial fibrillation.
- Cardiac arrythmia
- Pacemaker placement.
- Myocardial infarction < 3 months
- Uncontrolled diabetes mellitus with hemoglobin A1c > 8.5% in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Eldokla, MD principal investigator
Texas Tech Universty Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Neuropathy and Male Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.