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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01666964
Other study ID # 350758-12
Secondary ID
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


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
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