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 range18 Years â 64 Years
SexALL
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Inclusion criteria
â. veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91
â. age less than or equal to 64 years old
â. have a diagnosis of Gulf War Illness assessed by study investigators
â. 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)
â. 4-week stability on any psychotropic medications
â. 3-month stability on all hormone treatments
â. able and willing to provide informed consent to participant in the study and complete study protocol
Exclusion criteria
â. 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)
â. history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life
What they're measuring
1
Change in truncal fat mass from baseline to six months
â. 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
â. active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale
â. suicidal behavior in the past 6 months
â. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product
â. acute medical illness, active infection, cancer, or decompensated chronic medical illness (e.g., decompensated diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease)
â. 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.