Clinical Trial: Hormone Deficiency After Brain Injury During Combat

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population

Brief Summary: We would like to ascertain the prevalence of hypopituitarism after combat-related TBI. This will lead to enhanced awareness, recognition, and treatment of hypopituitarism, which can have life-saving ramifications and enhance quality of life and rehabilitation efforts in our combat veterans.

Detailed Summary: The prevalence of hypopituitarism after combat-related traumatic brain injury (TBI) is currently unknown. Recent civilian data on TBI show the prevalence of any pituitary hormone deficiency is as high as 80% after 12 months. While the military prevalence of hypopituitarism can be extrapolated from civilian data, a major limitation is the notably different mechanism of injury (i.e., blast) for military personnel compared to civilians (i.e., assaults, traffic accidents and falls). Little is known about the effect of shockwaves from a blast injury on central nervous system tissue, and due to the unique nature of blast-related TBI, the prevalence of pituitary dysfunction in affected service members may significantly differ from nonmilitary subjects in prior studies.
Sponsor: Walter Reed National Military Medical Center

Current Primary Outcome: Prevalence of anterior pituitary dysfunction [ Time Frame: at 3 (+/- 15 days) and 6 months (+/- 15 days) ]

Pituitary screening blood tests: cortisol, follicle stimulating hormone, luteinizing hormone, total testosterone (males) or estradiol (females), thyrotropin, free thyroxine, prolactin, insulin-like growth factor-1. Growth-hormone deficiency will be confirmed with a glucagon stimulation test. Adrenal Insufficiency will be confirmed with an Cosyntropin stimulation test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Prevalence of posterior pituitary dysfunction [ Time Frame: at 3 and 6 months ]

Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.


Original Secondary Outcome: Same as current

Information By: Walter Reed National Military Medical Center

Dates:
Date Received: August 14, 2012
Date Started: October 2012
Date Completion: May 2015
Last Updated: August 14, 2012
Last Verified: August 2012