Testosterone Replacement Therapy in Chronic Spinal Cord Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Hospital, Orthopedic, Endocrine |
| Therapuetic Areas: | Endocrinology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 11/3/2017 |
| Start Date: | August 2003 |
| End Date: | December 2012 |
It has long been recognized that co-morbidity associated with multiple metabolic syndrome,
such as adverse body composition, insulin resistance and autonomic nervous system impairment,
may lead to significant increase in cardiovascular morbidity and mortality. It is unclear
whether the co-morbidity evident in this population are due directly to their immobility or
are the result of unfavorable changes in their underlying hormonal milieu. The purpose of
this study is to determine the effect of testosterone replacement therapy in hypogonadal
males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy
expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
such as adverse body composition, insulin resistance and autonomic nervous system impairment,
may lead to significant increase in cardiovascular morbidity and mortality. It is unclear
whether the co-morbidity evident in this population are due directly to their immobility or
are the result of unfavorable changes in their underlying hormonal milieu. The purpose of
this study is to determine the effect of testosterone replacement therapy in hypogonadal
males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy
expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
This study is 24 months in duration. Men who have consented to pre-screening serum
testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l
will start testosterone replacement therapy after a 6-month baseline period. Once treatment
begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites
of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for
testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid
cream will be provided to the subjects should any skin irritations occur. If the patch causes
persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be
used. Detailed instructions and precautions using the gel are outlined in the consent form
and will be reviewed with the subject.
Those men who have consented to pre-screening serum testosterone and are found to have normal
levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate
as a control subject for the full 24-month period of the study. These subjects visit the lab
at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l
will start testosterone replacement therapy after a 6-month baseline period. Once treatment
begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites
of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for
testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid
cream will be provided to the subjects should any skin irritations occur. If the patch causes
persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be
used. Detailed instructions and precautions using the gel are outlined in the consent form
and will be reviewed with the subject.
Those men who have consented to pre-screening serum testosterone and are found to have normal
levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate
as a control subject for the full 24-month period of the study. These subjects visit the lab
at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
Inclusion Criteria:
- Males 18-49 years of age
- Chronic spinal cord injury
- Normal prostate specific antigen levels and digital rectal exam
- No known cardiovascular disease
- Subjects with total testosterone > 4 ng/ml
- Subjects with total testosterone > 4 ng/ml
Exclusion Criteria:
- Females
- Known coronary heart and/or artery disease, diabetes mellitus
- Previous or current cancer
- Current or previous anabolic steroid use
- Acute inter-current illness
- Abnormal liver function test (>1.5 times normal values) at baseline
- Prostate specific antigen above normal
- Abnormal digital rectal exam at baseline suggestive of malignancy
- Current alcohol or drug abuse
- Significant psychological disorders
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials