Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Last updated: May 14, 2026
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

3

Condition

Neurologic Disorders

Growth Hormone Deficiencies/abnormalities

Brain Injury

Treatment

Placebo

Somatropin

Clinical Study ID

NCT04867317
2018
  • Ages 21-55
  • All Genders

Study Summary

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. OEF/OIF/OND Veteran

  2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk andResilience Inventory-2 (DRRI-2)

  3. Age 21 - 55 years old

  4. One or more mTBI sustained during military service at least 12 months prior to thescreening date, as noted via the CRAFT survey.

  5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), orglucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/Lfor BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDSat baseline

  6. Score of 11 or more on QoL-AGHDA

  7. 4-week stability on any psychotropic medications

  8. 3-month stability on all other hormone treatments

  9. Able and willing to provide informed consent to participate in this study, andcomplete study protocol.

Exclusion

Exclusion Criteria:

  1. History of moderate or severe TBI

  2. History of neurologic disorder other than TBI with substantial impact on quality oflife

  3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder

  4. Active suicidal ideation (no plan required) as determined by a score of 2 points ormore on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideationrating, or overt suicidal behavior in the past 6 months.

  5. Contraindication to rhGH therapy

  6. Acute medical illness, active infection, cancer or decompensated chronic medicalillness

  7. Evidence of substance use disorder, -other than mild alcohol or cannabis usedisorder-, or urine toxicology evidence of the use of an illicit drug (excludingcannabis), in the past 6 months. Nicotine use is allowed.

  8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memoryand Malingering (TOMM).

  9. BMI > 40 or body weight > 350 lbs

  10. Pituitary anatomy documented by an MRI using a sella protocol within the last 2years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)

  11. Women who are pregnant or of child-bearing potential not on contraception

  12. Current use of the following: growth hormone, estrogen or estrogen-like dietarysupplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologicdoses

  13. Currently enrolled in any other interventional study unless prior approval isprovided by the study chairs and the study sponsor (Cooperative Studies Program)

Study Design

Total Participants: 172
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 13, 2025
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama 35233-1927
    United States

    Site Not Available

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California 94304-1207
    United States

    Site Not Available

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California 92161-0002
    United States

    Site Not Available

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado 80045-7211
    United States

    Site Not Available

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia 20422-0001
    United States

    Site Not Available

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida 33125
    United States

    Site Not Available

  • Miami VA Healthcare System, Miami, FL

    Miami 4164138, Florida 4155751 33125
    United States

    Site Not Available

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia 30033-4004
    United States

    Site Not Available

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur 4191124, Georgia 4197000 30033-4004
    United States

    Site Not Available

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan 48105-2303
    United States

    Site Not Available

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota 55417-2309
    United States

    Active - Recruiting

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis 5037649, Minnesota 5037779 55417-2309
    United States

    Site Not Available

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri 64128-2226
    United States

    Site Not Available

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska 68105-1850
    United States

    Site Not Available

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma 73104-5007
    United States

    Site Not Available

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas 75216-7167
    United States

    Site Not Available

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas 77030-4211
    United States

    Active - Recruiting

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas 78229-4404
    United States

    Site Not Available

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston 4699066, Texas 4736286 77030-4211
    United States

    Site Not Available

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington 98108-1532
    United States

    Active - Recruiting

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle 5809844, Washington 5815135 98108-1532
    United States

    Site Not Available

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