Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology, Endocrine |
| Therapuetic Areas: | Endocrinology, Neurology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/1/2018 |
| Start Date: | November 2003 |
| End Date: | October 2015 |
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires
hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by
GH stimulation testing. Moreover, abnormalities have also been established for the cortisol
and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients
with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle
function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,
thyroid, cortisol).
hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by
GH stimulation testing. Moreover, abnormalities have also been established for the cortisol
and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients
with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle
function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH,
thyroid, cortisol).
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in
adults following traumatic brain injury. Growth hormone deficiency will be replaced for a
period of one year. Subject will not be screened until at least one year following brain
injury to allow for natural recovery of hormone function.
adults following traumatic brain injury. Growth hormone deficiency will be replaced for a
period of one year. Subject will not be screened until at least one year following brain
injury to allow for natural recovery of hormone function.
Inclusion Criteria:
- Patients aged 21 and older.
- Documented moderate to severe traumatic brain injury at least one year post injury.
Exclusion Criteria:
- The only absolute exclusionary medication will be an anticoagulant (Coumadin) because
of the risk of bleeding during the possible muscle biopsy procedure and daily
injections of rhGH in the GH arm of the study.
- Any subject with a history of hepatitis or a 3-fold elevation of liver function tests
(Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are
uncertain of the effects of hormone replacement such as rhGH on the liver, so we will
exclude any subjects with hepatitis. This exclusion applies only to subjects who would
be enrolled in the GH arm of the study.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until
hormone abnormalities have been corrected.
- Subjects with chronic pain who are being managed with narcotics will be excluded as
the effects of central nervous system depressants may interfere with study test
results.
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