Actively Recruiting
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency
Led by VA Office of Research and Development · Updated on 2026-05-15
172
Participants Needed
17
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating growth hormone replacement therapy (GHRT) compared to a placebo to see if it improves quality of life in adults with growth hormone deficiency (AGHD) who also have mild traumatic brain injury (mTBI). This study focuses on adults aged 21 to 55 years who have a history of mild TBI sustained during military service and confirmed growth hormone deficiency. The trial aims to measure the impact of GHRT on quality of life using the Quality of Life-Assessment of Adult Growth Hormone in Adults (QoL-AGHDA) score. Participants will be randomly assigned to receive either recombinant human growth hormone (Somatropin) or a placebo for six months. The study is blinded so neither participants nor researchers know who receives the active treatment. Follow-up visits will take place on Days 14, 40, 65, 90 (3 months), and 180 (6 months) to monitor progress. After six months, treatment stops and participants are observed for an additional two weeks to ensure safety and help transition back to regular care. During the study, participants will undergo in-clinic assessments including quality of life questionnaires, body composition measurements, and safety monitoring. Researchers will compare changes in QoL-AGHDA scores between the two groups at six months. The total participation involves treatment and follow-up visits over approximately six months plus two weeks. This study is sponsored by the VA Office of Research and Development.
CONDITIONS
Brief Title
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- OEF/OIF/OND Veteran
- Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
- Aged between 21 and 55 years old
- One or more mild traumatic brain injuries sustained during military service at least 12 months before screening
- Diagnosed growth hormone deficiency confirmed by macimorelin or glucagon stimulation tests and IGF-I lab values at or below +1 SDS at baseline
- Score of 11 or more on Quality of Life-Assessment of Adult Growth Hormone in Adults (QoL-AGHDA)
- Stable on psychotropic medications for at least 4 weeks
- Stable on all other hormone treatments for at least 3 months
- Able and willing to provide informed consent and complete the study protocol
You will not qualify if you...
- History of moderate or severe traumatic brain injury
- History of neurological disorder other than traumatic brain injury significantly affecting quality of life
- History of bipolar disorder, schizophrenia, or other psychotic disorders
- Active suicidal thoughts or behavior within the past 6 months
- Contraindication to recombinant human growth hormone therapy
- Acute medical illness, active infection, cancer, or decompensated chronic illness
- Recent substance use disorder other than mild alcohol or cannabis use, or positive illicit drug test (excluding cannabis) within 6 months
- Score 41 or less on Trial 2 or Retention Trial of Test of Memory and Malingering (TOMM)
- Body mass index over 40 or weight greater than 350 pounds
- Pituitary abnormalities seen on MRI within last 2 years unrelated to mild traumatic brain injury
- Women who are pregnant or of childbearing potential not using contraception
- Current use of growth hormone, estrogen or estrogen-like supplements, progestin, IGF-I, or high-dose glucocorticoids
- Enrollment in other interventional studies without prior approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either recombinant human growth hormone or placebo for six months in a blinded randomized trial.
In-clinic follow-ups at Days 14, 40, 65, 90 (3 months), and 180 (6 months)
Duration - 2 weeks
Participants are followed up for two weeks after treatment ends to ensure safety and wellness and support transition back to routine care.
1 follow-up visit
Trial Site Locations
Total: 17 locations
1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
Not Yet Recruiting
2
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Not Yet Recruiting
3
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Not Yet Recruiting
4
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Not Yet Recruiting
5
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Not Yet Recruiting
6
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422-0001
Not Yet Recruiting
7
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Active, Not Recruiting
8
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Not Yet Recruiting
9
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
10
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128-2226
Not Yet Recruiting
11
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Not Yet Recruiting
12
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States, 28144
Not Yet Recruiting
13
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104-5007
Not Yet Recruiting
14
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Not Yet Recruiting
15
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
16
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229-4404
Not Yet Recruiting
17
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
Research Team
D
Deane V Walker, MHA BS AB
M
Michael T Wininger, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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