Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

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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