Clinical trial NCT01666964: Hormone Deficiency After Brain Injury During Combat
Official title: Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Hypopituitarism
Keywords: Traumatic brain injury
hypopituitarism
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: Novo Nordisk A/S
First posted: 2012-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury that occurred 3 and 6 months prior to enrollment.

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Combat veterans who are 3 or 6 months post combat-related TBI and age 18yrs or older
* Must demonstrate capacity for informed consent
* Must be DEERS eligible (Military healthcare beneficiary)

Exclusion Criteria:

* Pregnancy (to be assessed by urine HCG)
* Use of hormonal contraceptives
* Chronic oral or intravenous glucocorticoids
* Use of hormonal therapy to include estrogen and testosterone
* Prior diagnosis of hypopituitarism prior to combat related TBI

Primary outcomes:
measure: Prevalence of anterior pituitary dysfunction
timeFrame: at 3 (+/- 15 days) and 6 months (+/- 15 days)
Secondary outcomes:
measure: Prevalence of posterior pituitary dysfunction
timeFrame: at 3 and 6 months
Other outcomes:
measure: Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository
timeFrame: At completion of Enrollment
measure: Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index.
timeFrame: 3 and 6 months post-injury
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: WalterReed National Military Medical Center
name: Andrew J. Brackbill, M.D.
role: PRINCIPAL_INVESTIGATOR
References: