Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)

Exclusion Criteria14

• 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
• \) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor