Hormone Deficiency After Brain Injury During Combat

August 14, 2012 updated by: Walter Reed National Military Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • bTBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anterior pituitary dysfunction
Time Frame: at 3 (+/- 15 days) and 6 months (+/- 15 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of posterior pituitary dysfunction
Time Frame: at 3 and 6 months
Pituitary Dysfunction: Screening Sodium. Diabetes Insipidus will be confirmed with a water deprivation test.
at 3 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Background prevalence of hypopituitarism in a military population using the Department of Defense serum repository
Time Frame: At completion of Enrollment
Screening labs for pituitary dysfunction repeated on frozen serum obtained prior to injury.
At completion of Enrollment
Relationship between hypopituitarism secondary to combat-related TBI and symptom scores using the Neurobehavioral Symptom Index.
Time Frame: 3 and 6 months post-injury
The Neurobehavioral Symptom Index is a validated measure of cognitive and somatic symptoms after Traumatic Brain Injury.
3 and 6 months post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Andrew J. Brackbill, M.D., WalterReed National Military Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 350758-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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