Gulf War SyndromePhase 2GWITNCT05355272
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
A Phase 2 study testing Recombinant human growth hormone in people with Gulf War Syndrome and Adult Growth Hormone Deficiency, run by Baylor College of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Gulf War Syndrome, Adult Growth Hormone Deficiency
- What is being tested?
- Recombinant human growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2024to 1 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
- urine toxicology evidence of illicit drug use (excluding cannabis) within the past 90 days prior to screening
- BMI > 35 or body weight > 350 lbs
- abnormal pituitary anatomy documented by an MRI using a Sella protocol
- women who are pregnant or of child-bearing potential who are unable/unwilling to use one of the following barrier contraceptives: condoms, diaphragm, cervical cap, or intrauterine device
- current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, hormonal contraceptives, progestin, insulin growth factor 1 (IGF-1), or chronic glucocorticoid use in supraphysiologic doses
- 15) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Audri Villalon contact
United States2 sites, 2 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Dakota Broadway, dakota.broadway@bcm.edu
Ricardo Jorge, MD
- Recruiting
VA Puget Sound Healthcare System
Seattle, Washington, 98108
Megan Herodes, BS, megan.herodes@va.gov
Jose M Garcia, MD
About this study
Official title: Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency
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:
- 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?
- 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.
Read the detailed description
Veterans with Gulf War Illness (GWI) often experience a range of debilitating symptoms, including fatigue, chronic pain, depression, anxiety, and cognitive dysfunction. The factors contributing to these symptoms remain poorly understood, but adults with adult growth hormone deficiency (AGHD) experience similar symptoms. Growth hormone replacement therapy has been shown to improve fatigue, chronic pain, mood, cognitive function, and quality of life. Approximately 1 in 3 Veterans diagnosed with GWI also tests positive for AGHD, raising the question of whether growth hormone replacement therapy (GHRT) could be a potential avenue for improving their quality of life.
The objective of this research is to conduct a clinical trial to determine whether GHRT can improve body composition, cognitive function, sleep quality, fatigue, and mood in Veterans with GWI and AGHD. Data from this study will also provide important information on the safety of the intervention.
This research has the potential to reshape our understanding of GWI and its therapeutic management. If GHRT proves efficacious, it could prompt widespread screening and treatment for growth hormone deficiency among Gulf War Veterans, potentially ameliorating their symptoms and enhancing their functional recovery. Furthermore, the findings of this study may influence clinical practice guidelines, facilitating more effective communication and collaboration among Veterans, caregivers, researchers, and healthcare providers.
- Conditions
- Gulf War Syndrome, Adult Growth Hormone Deficiency
- Being tested
- Recombinant human growth hormone
- Keywords
- recombinant human growth hormone, growth hormone replacement therapy
- Medical subject headings
- Persian Gulf Syndrome, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human growth hormoneDrug
Also called Somatropin, Genotropin, Humatrope, Norditropin
recombinant human growth hormone (rhGH)
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone Replacement Therapy | Experimental | Patients will be started at a dose of 200-300 mcg/d of daily injections of GHRT. A biweekly titration period of 6 weeks will be performed in increments of 100 mcg/d as needed until IGF-1 levels are between +1 and +2 standard deviation score, up to a maximum dose of 2,000 mcg/d, provided the dose is well tolerated.
The duration of the intervention is 6-months. Participants will complete in-clinic follow-up visits at Days 14, 40, 65, 90, and 180. The primary outcome will be the change in truncal fat mass percentage from baseline to six months measured by dual-energy x-ray absorptiometry (DEXA). Receives: Drug: Recombinant human growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in truncal fat mass from baseline to six months
The primary outcome measure is the difference of truncal fat mass percentage from baseline to six months. Truncal fat mass will be assessed at baseline, 3-months, and 6-months using calibrated dual energy x-ray absorptiometry (DEXA). A large mean difference corresponds with greater changes in truncal fat mass. Decreased truncal fat mass is associated with reduced risk of cardiovascular disease.
Measured: 6 months
Secondary outcomes (6)
Cardiometabolic Risk Factors
Change in cardiometabolic risk factors from baseline to 6 months measured by fasting low density lipoproteins (LDL) and highly sensitive C-reactive protein levels. A decrease in lipoprotein corresponds with increased lipoprotein metabolism, and lower C-reactive protein levels corresponds with less inflammation. A reduction in both suggests lower risk of cardiometabolic disease.
Measured: 6 months
Lean body mass
The change in appendicular lean body mass between baseline and 6 months will be assessed using calibrated dual energy x-ray absorptiometry. The difference will capture changes in body composition (fat and muscle) with a higher difference corresponding with greater body composition changes.
Measured: 6 months
Assessment of quality of life
Change in the quality of life from baseline to 6 months will be measured by the Quality of Life questionnaire for Adult Growth Hormone Deficiency. The score ranges from 0 to 25, with a score of 25 representing highest symptomatic burden and lower quality of life. A change in score is positively correlated with the patient's perception of treatment benefit, and a score change of 3.5 points is considered clinically meaningful.
Measured: 6 months
Fatigue
Fatigue will be measured using the Fatigue Severity Scale. The questionnaire minimum score is a 9 and maximum score is 63. Higher scores represent greater fatigue severity.
Measured: 6 months
Depression, Anxiety, and Stress
The Depression, Anxiety, and Stress Scale-21 (DASS-21), a 21-item questionnaire, will be used to assess depression, anxiety, and stress symptoms. The score range is 0 - 126 with a higher score representing greater severity or frequency of negative emotional symptoms.
Measured: 6 months
Pain Intensity and Interference
Pain intensity and interference will be assessed using the Defense and Veterans Pain Rating Scale. The questionnaire contains two sections, one assessing current level of pain and the other evaluating the extent to which pain interferes with biopsychosocial factors such as daily activity, sleep, mood, and stress. The minimum score for each section is 0 and maximum score is 10 where higher scores correspond with more intense pain and greater interference.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm futility trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Ricardo Jorge, MD, Baylor College of Medicine
- Investigators
- Ricardo Jorge, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355272
- Sponsor's protocol ID
- H-49490
- Other IDs
- CDMRP-GW200072
- Acronym
- GWIT
- Status last verified
- May 2026
- First submitted
- 20 Apr 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings in this study may be made available upon request to VA and non-VA researchers in accordance to VA policy.