Recruiting
Phase 2

Growth Hormone

Sponsor:

Baylor College of Medicine

Code:

NCT05355272

Conditions

Gulf War Syndrome

Adult Growth Hormone Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Recombinant human growth hormone

Study Details

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). 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.

Conditions

Gulf War Syndrome

Adult Growth Hormone Deficiency

Study ID

NCT05355272

Start date

Mar 11, 2024

Status verified date

May, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Growth Hormone Replacement Therapy

Patients will be started at a dose of 200-300 mcg/d of daily injections of GHRT. A biweekly titration period of 6 weeks will be performed in increments of 100 mcg/d as needed until IGF-1 levels are between +1 and +2 standard deviation score, up to a maximum dose of 2,000 mcg/d, provided the dose is well tolerated.

The duration of the intervention is 6-months. Participants will complete in-clinic follow-up visits at Days 14, 40, 65, 90, and 180. The primary outcome will be the change in truncal fat mass percentage from baseline to six months measured by dual-energy x-ray absorptiometry (DEXA).

Interventions

Recombinant human growth hormone

recombinant human growth hormone (rhGH)

Primary outcome measure

  • Change in truncal fat mass from baseline to six months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Ricardo Jorge, MD

VA Puget Sound Healthcare System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Megan Herodes, BS

megan.herodes@va.gov

Principal Investigator:

Jose M Garcia, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • recombinant human growth hormone
  • growth hormone replacement therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-05-08.