Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT) (NCT05355272) | Clinical Trial Compass
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
United States20 participantsStarted 2024-03-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91
. age less than or equal to 64 years old
. have a diagnosis of Gulf War Illness assessed by study investigators
. have adult growth hormone deficiency diagnosed by glucagon stimulation test (cut point 3.0 mcg/L if BMI is less than or equal to 25 or 1.0 mcg/L if BMI is greater than 25)
. 4-week stability on any psychotropic medications
. 3-month stability on all hormone treatments
. able and willing to provide informed consent to participant in the study and complete study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in relatively early testing — can you help me understand what that means for how much is already known about the safety and effectiveness of growth hormone replacement for Gulf War Illness and adult growth hormone deficiency together?
2The trial's main thing it's measuring is change in truncal fat mass over six months — does that outcome actually connect to the Gulf War Illness symptoms I'm most struggling with, or are there other benefits or risks I should weigh alongside that?
3Growth hormone therapy can have real side effects — based on my current health, what risks would you want to monitor most closely if I were receiving this treatment as part of a research study?
4Since the trial is actively recruiting right now, what would the actual commitment look like for me in terms of clinic visits, testing, or time over those six months, and is that realistic given my situation?
5Are there standard treatments for adult growth hormone deficiency that I should consider first, or would you say this trial might be worth exploring instead of or alongside what's already available outside of a study??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in truncal fat mass from baseline to six months
. history of a psychiatric disorder with substantial impact on functional status or quality of life (e.g., schizophrenia, schizoaffective disorder, bipolar, or other psychotic disorder)
. history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life
. other known cause for growth hormone deficiency (GHD) including history of childhood onset GHD, hypothalamic/pituitary disease, history of brain radiation, or genetic mutations known to lead to GHD
. active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale
. suicidal behavior in the past 6 months
. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product
. acute medical illness, active infection, cancer, or decompensated chronic medical illness (e.g., decompensated diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease)
. evidence of substance use disorder in the past 6 months other than mild alcohol or cannabis use disorder diagnosed by clinician at time of screening.