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

Eligibility Criteria

• 1. veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91
• 2. age less than or equal to 64 years old
• 3. have a diagnosis of Gulf War Illness assessed by study investigators
• 4. 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)
• 5. 4-week stability on any psychotropic medications
• 6. 3-month stability on all hormone treatments
• 7. able and willing to provide informed consent to participant in the study and complete study protocol
• 1. 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)
• 2. history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life
• 3. 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
• 4. active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale
• 5. suicidal behavior in the past 6 months
• 6. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product
• 7. acute medical illness, active infection, cancer, or decompensated chronic medical illness (e.g., decompensated diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease)
• 8. 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.
• 9. urine toxicology evidence of illicit drug use (excluding cannabis) within the past 90 days prior to screening
• 10. BMI \> 35 or body weight \> 350 lbs
• 11. abnormal pituitary anatomy documented by an MRI using a Sella protocol
• 12. 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
• 13. 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