Actively Recruiting
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Led by Baylor College of Medicine · Updated on 2026-05-08
20
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of the GWIT Study is to assess whether growth hormone replacement therapy is a safe and effective treatment for veterans with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). The main questions the study aims to answer are: 1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency? 2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness? To determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial.
CONDITIONS
Official Title
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran of the Gulf War conflict with deployment to Operation Desert Storm or Desert Shield between 1990-91
- Age less than or equal to 64 years old
- Diagnosed with Gulf War Illness as assessed by study investigators
- Diagnosed with adult growth hormone deficiency by glucagon stimulation test (cut point 3.0 mcg/L if BMI ≤ 25 or 1.0 mcg/L if BMI > 25)
- Stable on any psychotropic medications for at least 4 weeks
- Stable on all 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 psychiatric disorders severely impacting function or quality of life (e.g., schizophrenia, schizoaffective disorder, bipolar, or other psychotic disorders)
- History of neurologic disorders other than traumatic brain injury that severely impact quality of life
- Other known causes of growth hormone deficiency such as childhood onset GHD, hypothalamic/pituitary disease, brain radiation history, or genetic mutations causing GHD
- Active suicidal thoughts (score of 2 or higher on Columbia Suicide Severity Rating Scale)
- Suicidal behavior in the past 6 months
- Contraindications to recombinant human growth hormone such as hypersensitivity
- Acute medical illness, active infection, cancer, or decompensated chronic illnesses (e.g., diabetes, heart failure, COPD)
- Substance use disorder in past 6 months except mild alcohol or cannabis use diagnosed at screening
- Urine toxicology showing illicit drug use (excluding cannabis) within past 90 days
- Body mass index over 35 or body weight over 350 lbs
- Abnormal pituitary anatomy shown by MRI with Sella protocol
- Women who are pregnant or of childbearing potential unable or unwilling to use barrier contraception
- Current use of growth hormone, estrogen or estrogen-like supplements, hormonal contraceptives, progestin, IGF-1, or high-dose glucocorticoids
- Currently enrolled in other interventional drug trials without prior approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
2
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
L
Lane Witkowski
CONTACT
A
Audri Villalon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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