Hormone Deficiency After Brain Injury During Combat

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Traumatic Brain Injury, Hypopituitarism

Intervention / Treatment
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* Other: Blast Traumatic Brain Injury


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3 months post-injury<br>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 | Other: Blast Traumatic Brain Injury<br>* Exposure during combat to blast-wave mediated Traumatic Brain Injury<br>* Other names: bTBI;|
| 6 months post-injury<br>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 | Other: Blast Traumatic Brain Injury<br>* Exposure during combat to blast-wave mediated Traumatic Brain Injury<br>* Other names: bTBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, hypopituitarism