Hormone Deficiency After Brain Injury During Combat
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Hypopituitarism |
Other: Blast Traumatic Brain Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population |
- Prevalence of anterior pituitary dysfunction [ Time Frame: at 3 (+/- 15 days) and 6 months (+/- 15 days) ] [ Designated as safety issue: No ]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.
- Prevalence of posterior pituitary dysfunction [ Time Frame: at 3 and 6 months ] [ Designated as safety issue: No ]Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.
- Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository [ Time Frame: At completion of Enrollment ] [ Designated as safety issue: No ]Screening labs for pituitary dysfunction repeated on frozen serum obtained prior to injury.
- Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index. [ Time Frame: 3 and 6 months post-injury ] [ Designated as safety issue: No ]The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury.
Biospecimen Retention: Samples Without DNA
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
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Other: Blast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Other Name: bTBI
|
|
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
|
Other: Blast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Other Name: bTBI
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations| Contact: Andrew J Brackbill, M.D. | 301-295-5183 | tbiendocrine@gmail.com |
| United States, Maryland | |
| Walter Reed National Military Medical Center | Not yet recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Principal Investigator: Andrew J Brackbill, M.D. | |
| Sub-Investigator: Kate H Kinnaird, M.D. | |
| Sub-Investigator: Louis French, PhD | |
| Sub-Investigator: Patrick W. Clyde, M.D. | |
| Sub-Investigator: Peter McIntyre, M.D. | |
| Principal Investigator: | Andrew J. Brackbill, M.D. | WalterReed National Military Medical Center |
More Information
No publications provided
| Responsible Party: | Walter Reed National Military Medical Center |
| ClinicalTrials.gov Identifier: | NCT01666964 History of Changes |
| Other Study ID Numbers: | 350758-12 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Walter Reed National Military Medical Center:
|
Traumatic brain injury hypopituitarism |
Additional relevant MeSH terms:
|
Hypopituitarism Brain Injuries Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013