Status:
RECRUITING
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
United States Department of Defense
Conditions:
Gulf War Syndrome
Adult Growth Hormone Deficiency
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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)...
Detailed Description
Veterans with Gulf War Illness (GWI) often experience a range of debilitating symptoms, including fatigue, chronic pain, depression, anxiety, and cognitive dysfunction. The factors contributing to the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 15\) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05355272
Start Date
March 11 2024
End Date
July 1 2026
Last Update
August 11 2025
Active Locations (2)
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1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
2
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108