Hormone Deficiency After Brain Injury During Combat

• Conditions: Hypopituitarism; Traumatic Brain Injury
• Interventions: Other: Blast Traumatic Brain Injury

• Registration Number: NCT01666964
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16
• Study Start: 2012-10
• Primary Completion: 2014-12
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3 months post-injury	Blast Traumatic Brain 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	Blast Traumatic Brain 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Prevalence of posterior pituitary dysfunction	at 3 and 6 months	Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States