Hypopituitarism, Traumatic Brain Injury
Conditions
Keywords
Traumatic brain injury, hypopituitarism
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.
Interventions
OTHERBlast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Sponsors
Novo Nordisk A/S
Walter Reed National Military Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of anterior pituitary dysfunction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of posterior pituitary dysfunction | at 3 and 6 months | Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository | At completion of Enrollment | Screening labs for pituitary dysfunction repeated on frozen serum obtained prior to injury. |
| Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index. | 3 and 6 months post-injury | The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury. |
Countries
United States
Contacts
Primary ContactAndrew J Brackbill, M.D.
Outcome results
None listed