RecruitingPhase 2NCT05355272

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

Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency


Sponsor

Baylor College of Medicine

Enrollment

20 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing growth hormone replacement therapy in Gulf War veterans who have both Gulf War Illness (a chronic multi-symptom disorder) and adult growth hormone deficiency. Researchers want to see whether replacing deficient growth hormone improves veterans' energy, cognition, and overall quality of life. You may be eligible if... - You are a veteran who was deployed to Operation Desert Storm or Desert Shield between 1990-1991 - You are 64 years old or younger - You have been diagnosed with Gulf War Illness - You have adult growth hormone deficiency confirmed by a glucagon stimulation test - Your psychotropic medications have been stable for at least 4 weeks - Your hormone treatments have been stable for at least 3 months You may NOT be eligible if... - You have a serious psychiatric disorder such as schizophrenia, bipolar disorder, or a psychotic disorder - You have another neurological disorder significantly affecting your quality of life - You have active suicidal ideation or a recent suicide attempt (within the last 6 months) - You have an active infection, cancer, or serious uncontrolled medical illness - Your BMI is over 35 or you weigh more than 350 lbs - You have a known allergy or contraindication to growth hormone therapy - You are a woman of childbearing potential unwilling to use contraception - You are currently on growth hormone, estrogen supplements, hormonal contraceptives, or similar medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant human growth hormone

recombinant human growth hormone (rhGH)


Locations(2)

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

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NCT05355272


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