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Hormone Deficiency After Brain Injury During Combat

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Walter Reed National Military Medical Center
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01666964
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

August 14, 2012
August 14, 2012
October 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
  • 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.
Same as current
 
Hormone Deficiency After Brain Injury During Combat
Prevalence of Hypopituitarism Following Combat-related Traumatic Brain Injury in a Military Population

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

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.

  • Traumatic Brain Injury
  • Hypopituitarism
Other: Blast Traumatic Brain Injury
Exposure during combat to blast-wave mediated Traumatic Brain Injury
Other Name: bTBI
  • 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
    Intervention: Other: Blast Traumatic Brain Injury
  • 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
    Intervention: Other: Blast Traumatic Brain Injury
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
May 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andrew J Brackbill, M.D. 301-295-5183 tbiendocrine@gmail.com
United States
 
NCT01666964
350758-12
No
Walter Reed National Military Medical Center
Walter Reed National Military Medical Center
Novo Nordisk A/S
Principal Investigator: Andrew J. Brackbill, M.D. WalterReed National Military Medical Center
Walter Reed National Military Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP