Hormone Deficiency After Brain Injury During Combat

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01666964
• Other study ID #: 350758-12
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 14, 2012
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2012
• Source: Walter Reed National Military Medical Center
• Contact: Andrew J Brackbill, M.D.
• Phone: 301-295-5183
• Email: tbiendocrine[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Hypopituitarism
• Traumatic Brain Injury

Intervention

Other:
• Blast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index.	The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury.	3 and 6 months post-injury	No
Primary	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)	No
Secondary	Prevalence of posterior pituitary dysfunction	Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.	at 3 and 6 months	No