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

Last updated: July 11, 2024
Sponsor: Baylor College of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Growth Hormone Deficiencies/abnormalities

Treatment

Placebo

Recombinant human growth hormone

Clinical Study ID

NCT05355272
H-49490
CDMRP-GW200072
  • Ages 18-64
  • All Genders

Study 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). The main questions the study aims to answer are:

  1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency?

  2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness?

To determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. veteran of the Gulf War conflict with a history of deployment to Operation DesertStorm 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 (cutpoint 3.0 mcg/L if BMI is less than or equal to 25 or 1.0 mcg/L if BMI is greaterthan 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 andcomplete study protocol

Exclusion

Exclusion Criteria:

  1. history of a psychiatric disorder with substantial impact on functional status orquality of life (e.g., schizophrenia, schizoaffective disorder, bipolar, or otherpsychotic disorder)

  2. history of neurologic disorder other than traumatic brain injury with substantialimpact on the quality of life

  3. 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

  4. active suicidal ideation as determined by a score of 2 points or higher on theColumbia Suicide Severity Rating Scale

  5. suicidal behavior in the past 6 months

  6. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivityto rhGH or any of the components of the supplied product

  7. acute medical illness, active infection, cancer, or decompensated chronic medicalillness (e.g., decompensated diabetes mellitus, congestive heart failure, chronicobstructive pulmonary disease)

  8. evidence of substance use disorder in the past 6 months other than mild alcohol orcannabis 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 useone of the following barrier contraceptives: condoms, diaphragm, cervical cap, orintrauterine device

  13. 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

  1. currently enrolled in any other interventional drug trials unless prior approval isprovided by the study chairs and the study sponsor

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 12, 2024
Estimated Completion Date:
September 30, 2025

Study 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 these symptoms remain poorly understood, but adults with adult growth hormone deficiency (AGHD) experience similar symptoms. Growth hormone replacement therapy has been shown to improve fatigue, chronic pain, mood, cognitive function, and quality of life. Approximately 1 in 3 Veterans diagnosed with GWI also tests positive for AGHD, raising the question of whether growth hormone replacement therapy (GHRT) could be a potential avenue for improving their quality of life.

The objective of this research is to conduct a clinical trial to determine whether GHRT can improve body composition, cognitive function, sleep quality, fatigue, and mood in Veterans with GWI and AGHD. Data from this study will also provide important information on the safety of the intervention.

This research has the potential to reshape our understanding of GWI and its therapeutic management. If GHRT proves efficacious, it could prompt widespread screening and treatment for growth hormone deficiency among Gulf War Veterans, potentially ameliorating their symptoms and enhancing their functional recovery. Furthermore, the findings of this study may influence clinical practice guidelines, facilitating more effective communication and collaboration among Veterans, caregivers, researchers, and healthcare providers.

Connect with a study center

  • Michael E. DeBakey VA Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • VA Puget Sound Healthcare System

    Seattle, Washington 98108
    United States

    Active - Recruiting

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