Growth hormone therapy for veterans with Gulf War Illness and hormone deficiency
Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency
PHASE2 · Baylor College of Medicine · NCT05355272
This study is testing if growth hormone therapy can help veterans with Gulf War Illness and hormone deficiency feel better by reducing symptoms like fatigue and pain.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT05355272 on ClinicalTrials.gov |
What this trial studies
The GWIT Study aims to evaluate the safety and effectiveness of growth hormone replacement therapy in veterans suffering from Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). Participants will undergo various assessments, including questionnaires, blood tests, and brain scans, to determine eligibility. Those who qualify will receive recombinant human growth hormone for six months, with body composition and cognitive function monitored throughout the intervention. The study seeks to understand if this therapy can alleviate symptoms such as fatigue, chronic pain, and cognitive dysfunction associated with GWI.
Who should consider this trial
Good fit: Ideal candidates are Gulf War veterans aged 64 or younger with a diagnosis of Gulf War Illness and confirmed adult growth hormone deficiency.
Not a fit: Patients with significant psychiatric or neurologic disorders that impact their quality of life may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for veterans suffering from GWI and AGHD.
How similar studies have performed: Previous studies have indicated potential benefits of growth hormone therapy in similar populations, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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 15\) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor
Where this trial is running
Houston, Texas and 1 other locations
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States (RECRUITING)
- VA Puget Sound Healthcare System — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Ricardo Jorge, MD — Baylor College of Medicine
- Study coordinator: Lane Witkowski
- Email: Lane.Witkowski@bcm.edu
- Phone: (206) 419-1261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gulf War Syndrome, Adult Growth Hormone Deficiency, recombinant human growth hormone, growth hormone replacement therapy