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

NCT05355272 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: H-49490CDMRP-GW200072
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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. 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. 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?

Conditions

Gulf War Syndrome; Adult Growth Hormone Deficiency

Keywords

recombinant human growth hormone; growth hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• Change in truncal fat mass from baseline to six months

  The primary outcome measure is the difference of truncal fat mass percentage from baseline to six months. Truncal fat mass will be assessed at baseline, 3-months, and 6-months using calibrated dual energy x-ray absorptiometry (DEXA). A large mean difference corresponds with greater changes in truncal fat mass. Decreased truncal fat mass is associated with reduced risk of cardiovascular disease.

  6 months

Secondary Outcomes (6)

• Cardiometabolic Risk Factors

  6 months

• Lean body mass

  6 months

• Assessment of quality of life

  6 months

• Fatigue

  6 months

• Depression, Anxiety, and Stress

  6 months

Study Arms (1)

Growth Hormone Replacement Therapy

EXPERIMENTAL

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).

Drug: Recombinant human growth hormone

Interventions

Recombinant human growth hormone DRUG

recombinant human growth hormone (rhGH)

Also known as: Somatropin, Genotropin, Humatrope, Norditropin

Growth Hormone Replacement Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• week stability on any psychotropic medications
• month stability on all hormone treatments
• able and willing to provide informed consent to participant in the study and complete study protocol

You may not qualify if:

• 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
• \) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor

Sponsors & Collaborators

• Baylor College of Medicine: lead
• United States Department of Defense: collaborator

Study Sites (2)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome; Dwarfism, Pituitary

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ricardo Jorge, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dakota Broadway, MS

CONTACT

(281) 896-0787; dakota.broadway@bcm.edu

Audri Villalon

CONTACT

(281) 896-0787; audri.villalon@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Model Details: This is a single-arm futility trial.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: March 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available up to 24 months after article publication.
• Access Criteria: Access to trial data can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal, statistical analysis plan, and data usage agreement.

Locations

US (2)