Growth hormone therapy for veterans with Gulf War Illness and hormone deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Easy-to-Use Growth Hormone Deficiency Treatment: A New Injectable for Adults

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• Cranial electrical stimulation with brain imaging for Gulf War illness headaches and pain

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• GenSci134 in healthy adults and adults with growth hormone deficiency

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• Acupuncture for relieving symptoms of Gulf War Illness

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• Belgians and Luxembourgians with childhood GHD: adult outcomes and follow-up

  This study tests how adults who had childhood-onset growth hormone deficiency and were treated with rhGH fare in follow-up and ongoing treatment.

  Recruiting Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Brussels, Woluwe-saint-lambert · NCT06694506

• Using Coenzyme Q10 to help veterans with Gulf War illness

  This study is testing if a special form of coenzyme Q10 can help veterans with Gulf War illness feel better and improve their quality of life.

  Recruiting Phase 3 University of California, San Diego · La Jolla, California · NCT06515184

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.