Hormone Deficiency After Brain Injury During Combat
Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 16, 2012
August 1, 2012
2.2 years
August 14, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prevalence of posterior pituitary dysfunction
at 3 and 6 months
Other Outcomes (2)
Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository
At completion of Enrollment
Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index.
3 and 6 months post-injury
Study Arms (2)
3 months post-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
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
Interventions
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Eligibility Criteria
Male and female combat veterans age 18 years and older with the diagnosis of Traumatic Brain Injury that occurred 3 and 6 months prior to enrollment.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Walter Reed National Military Medical Centerlead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Biospecimen
No specimens will be stored. Blood Testing: Testosterone 2ml Estradiol 2ml LH/FSH 3ml Prolactin 2ml IGF-1 1ml TSH 2ml Free T4 1ml Sodium 2ml Total blood for cosyntropin stim test 9ml Total blood for glucagon stim test 15ml Water deprivation testing 12ml-32ml Urine Testing: HCG 2ml Water deprivation testing 8ml-18ml
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J. Brackbill, M.D.
WalterReed National Military Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
August 16, 2012
Record last verified: 2012-08