Brief Title
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Official Title
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Brief Summary
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).
Detailed Description
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Maximum Oxygen Uptake at Baseline.
Secondary Outcome
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
Condition
Growth Hormone Deficiency
Intervention
Recombinant human growth hormone
Study Arms / Comparison Groups
Human Growth Hormone
Description: recombinant human growth hormone (rhGH) self administered daily for one year
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
November 2003
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
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.
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Randall J Urban, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00957671
Organization ID
03-034
Responsible Party
Sponsor
Study Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
Study Sponsor
Randall J Urban, M.D., Principal Investigator, The University of Texas Medical Branch at Galveston
Verification Date
May 2018