Actively Recruiting
Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency
Led by Baylor College of Medicine · Updated on 2026-05-08
20
Participants Needed
2
Research Sites
30 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
This research aims to evaluate the safety and effectiveness of growth hormone replacement therapy (GHRT) in veterans diagnosed with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). Veterans with GWI often have symptoms like fatigue, chronic pain, depression, anxiety, and cognitive problems, which overlap with symptoms seen in AGHD. The study will explore if GHRT can reduce trunk fat and improve these symptoms, and whether a larger trial is warranted to further investigate GHRT's benefits for this group. Participants will receive daily injections of recombinant human growth hormone starting at 200-300 mcg per day. The dose may be adjusted every two weeks over six weeks to reach target IGF-1 levels, with a maximum dose of 2,000 mcg per day as tolerated. The treatment lasts six months, with follow-up visits at days 14, 40, 65, 90, and 180. Body composition scans will measure trunk fat at the start, midpoint, and end of treatment. During the trial, veterans will complete questionnaires and cognitive tests before and after treatment. Researchers will assess changes in trunk fat, lean body mass, quality of life, fatigue, mood symptoms, pain, and cardiometabolic risk factors. Safety and treatment adherence will be monitored throughout. The total participation period includes screening and six months of therapy with multiple clinical visits and assessments.
CONDITIONS
Brief 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 18 to 64 years old
- Diagnosed with Gulf War Illness by study investigators
- Diagnosed with adult growth hormone deficiency by glucagon stimulation test
- Stable on 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 significantly affecting function or quality of life (e.g., schizophrenia, bipolar disorder)
- History of neurological disorders other than traumatic brain injury affecting quality of life
- Known causes of growth hormone deficiency other than adult onset (e.g., childhood onset, pituitary disease, brain radiation)
- Active suicidal ideation or recent suicidal behavior
- Hypersensitivity or contraindication to recombinant human growth hormone
- Acute or decompensated medical illnesses including infection, cancer, heart failure, or COPD
- Recent substance use disorder or illicit drug use (excluding mild alcohol or cannabis use)
- BMI over 35 or body weight over 350 lbs
- Abnormal pituitary anatomy on MRI
- Women pregnant or of child-bearing potential unwilling to use barrier contraception
- Current use of growth hormone or certain hormonal medications
- Participation in other interventional drug trials without prior approval by study chairs and sponsor
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 weeks
Participants undergo a biweekly titration period to adjust growth hormone dosage based on IGF-1 levels and tolerance.
Visits at Days 14, 40, and 65 (in-person)
Duration - 6 months
Participants receive daily injections of recombinant human growth hormone to improve body composition, cognitive function, sleep quality, fatigue, and mood.
Visits at Days 90 and 180 (in-person)
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
A
Audri Villalon
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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