Phase
Condition
Growth Hormone Deficiencies/abnormalities
Treatment
Placebo
Recombinant human growth hormone
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
veteran of the Gulf War conflict with a history of deployment to Operation DesertStorm 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 (cutpoint 3.0 mcg/L if BMI is less than or equal to 25 or 1.0 mcg/L if BMI is greaterthan 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 andcomplete study protocol
Exclusion
Exclusion Criteria:
history of a psychiatric disorder with substantial impact on functional status orquality of life (e.g., schizophrenia, schizoaffective disorder, bipolar, or otherpsychotic disorder)
history of neurologic disorder other than traumatic brain injury with substantialimpact on the quality of life
other known cause for growth hormone deficiency (GHD) including history of childhoodonset GHD, hypothalamic/pituitary disease, history of brain radiation, or geneticmutations known to lead to GHD
active suicidal ideation as determined by a score of 2 points or higher on theColumbia Suicide Severity Rating Scale
suicidal behavior in the past 6 months
contraindication to recombinant human growth hormone (rhGH) such as hypersensitivityto rhGH or any of the components of the supplied product
acute medical illness, active infection, cancer, or decompensated chronic medicalillness (e.g., decompensated diabetes mellitus, congestive heart failure, chronicobstructive pulmonary disease)
evidence of substance use disorder in the past 6 months other than mild alcohol orcannabis 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 useone of the following barrier contraceptives: condoms, diaphragm, cervical cap, orintrauterine device
current use of the following: growth hormone, estrogen or estrogen-like dietarysupplements, hormonal contraceptives, progestin, insulin growth factor 1 (IGF-1), orchronic glucocorticoid use in supraphysiologic doses
- currently enrolled in any other interventional drug trials unless prior approval isprovided by the study chairs and the study sponsor
Study Design
Study Description
Connect with a study center
Michael E. DeBakey VA Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
VA Puget Sound Healthcare System
Seattle, Washington 98108
United StatesActive - Recruiting
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