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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months post-injury | Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 3 months prior to enrollment, 50% mild, 50% moderate and severe |
| |
| 6 months post-injury | Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury caused by a blast that occurred 6 months prior to enrollment, 50% mild, 50% moderate and severe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blast Traumatic Brain Injury | Other | Exposure during combat to blast-wave mediated Traumatic Brain Injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of anterior pituitary dysfunction | 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. | at 3 (+/- 15 days) and 6 months (+/- 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of posterior pituitary dysfunction | Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test. | at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository | Screening labs for pituitary dysfunction repeated on frozen serum obtained prior to injury. | At completion of Enrollment |
| Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew J Brackbill, M.D. | Contact | 301-295-5183 | tbiendocrine@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew J. Brackbill, M.D. | WalterReed National Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D007018 | Hypopituitarism |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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No specimens will be stored.
Blood Testing:
Testosterone 2ml Estradiol 2ml LH/FSH 3ml Prolactin 2ml IGF-1 1ml TSH 2ml Free T4 1ml Sodium 2ml Total blood for cosyntropin stim test 9ml Total blood for glucagon stim test 15ml Water deprivation testing 12ml-32ml
Urine Testing:
HCG 2ml Water deprivation testing 8ml-18ml
The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury. |
| 3 and 6 months post-injury |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |