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
  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

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666964

Contacts
Contact: Andrew J Brackbill, M.D. 301-295-5183 tbiendocrine@gmail.com

Locations
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.         
Sponsors and Collaborators
Walter Reed National Military Medical Center
Novo Nordisk A/S
Investigators
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pituitary Diseases
Hypothalamic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014