NCT05355272|RecruitingPhase 2DMCFDA Drug
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
GWIT
Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency
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Sponsor study identifier
Secondary identifiers
OTHER · CDMRP
interventional
20
1 country
2
Study Start
March 11, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2022
Actual (reported)May 2, 2022
Actual (reported)March 11, 2024
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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).
recombinant human growth hormone (rhGH)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Ricardo Jorge, MD
Baylor College of Medicine
First Submitted
April 20, 2022
First Posted
May 2, 2022
Study Start
March 11, 2024
Actual (reported)Primary Completion
December 2026
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2026
Record last verified: 2026-05
The data supporting the findings in this study may be made available upon request to VA and non-VA researchers in accordance to VA policy.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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