Actively Recruiting
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Led by VA Office of Research and Development · Updated on 2026-04-09
172
Participants Needed
4
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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...
- Veteran of OEF/OIF/OND operations
- Age between 21 and 55 years
- One or more mild traumatic brain injuries sustained during military service at least 12 months before screening
- Diagnosed adult growth hormone deficiency confirmed by macimorelin stimulation test and IGF-I lab values
- Score of 18 or more on Combat Experiences sub-scale of DRRI-2
- Score of 11 or more on 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 study protocol
You will not qualify if you...
- History of moderate or severe traumatic brain injury
- History of neurological disorders other than TBI that significantly affect quality of life
- History of bipolar disorder, schizophrenia, or other psychotic disorders
- Active suicidal thoughts or behavior within the past 6 months
- Contraindications to rhGH therapy or macimorelin use, including prolonged QTc interval
- Acute medical illness, active infection, cancer, or unstable chronic medical illness
- Substance use disorder other than mild alcohol or cannabis use, or positive urine toxicology for illicit drugs (excluding cannabis) in past 6 months
- Score less than or equal to 41 on specific memory malingering tests
- Body mass index over 35 or weight over 350 pounds
- Pituitary abnormalities on MRI consistent with causes other than mild TBI
- 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
- Participation in another interventional study without prior approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
2
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
3
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
4
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
CONTACT
M
Michael T Wininger, PhD
CONTACT
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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