BridgeMD
New treatment option for Gulf War Syndrome
Official title Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
ClinicalTrials.gov ID: NCT05355272
What this study is testing
What is Recombinant human growth hormone?
Recombinant human growth hormone is an investigational medicine, being studied as a potential treatment for gulf war syndrome.
Also referred to as Somatropin, Genotropin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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...
- 4-week stability on any psychotropic medications
You likely can't join if
- history of a psychiatric disorder with substantial impact on functional status or quality of life (e.g., schizophrenia, schizoaffective 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...
- 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
See the full eligibility 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
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.