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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05355272
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Adult Growth Hormone Deficiency
  • Gulf War Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Recombinant human growth hormone — DRUG
    recombinant human growth hormone (rhGH)

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical CenterHoustonTexas77030
Dakota Broadway
[email protected]
Ricardo Jorge, MD (PRINCIPAL_INVESTIGATOR)
VA Puget Sound Healthcare SystemSeattleWashington98108
Megan Herodes, BS
[email protected]
Jose M Garcia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Michael E. DeBakey VA Medical Center· Houston, TXVA Puget Sound Healthcare System· Seattle, WA

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