Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of anterior pituitary dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Prevalence of anterior pituitary dysfunction
时间窗: 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.
次要结局
- Prevalence of posterior pituitary dysfunction(at 3 and 6 months)