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Hormone Therapy

Growth Hormone Replacement for Gulf War Illness (GWIT Trial)

Phase 2
Recruiting
Led By Ricardo Jorge, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age less than or equal to 64 years old
Diagnosis of Gulf War Illness assessed by study investigators
Must not have
Contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing if giving synthetic growth hormone to veterans with Gulf War Illness and growth hormone deficiency can reduce body fat and improve their symptoms. The study will check if this treatment is safe and effective over several months. If successful, it could lead to better care for these veterans. Growth hormone (GH) treatment has been shown to increase height velocity in children with Prader-Willi syndrome, decrease weight-for-height index values and body fat mass, and have a positive effect on lean body mass during therapy.

Who is the study for?
This trial is for Gulf War veterans under 65 with Gulf War Illness and Adult Growth Hormone Deficiency, who are stable on current medications. They must not be pregnant, in other drug trials without approval, have certain psychiatric or neurological disorders, recent illicit drug use (except cannabis), extreme obesity, or a history of growth hormone issues due to other causes.
What is being tested?
The study tests if Growth Hormone Replacement Therapy (GHRT) over six months can reduce belly fat in these veterans compared to a placebo. It's a double-blind trial meaning neither the participants nor the researchers know who gets GHRT or placebo until after the results are collected.
What are the potential side effects?
Possible side effects of recombinant human growth hormone include joint and muscle pain, swelling due to fluid in the body's tissues, carpal tunnel syndrome-like symptoms, increased cholesterol levels and potential contribution to diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 64 years old or younger.
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I have been diagnosed with Gulf War Illness by the study's doctors.
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I have been diagnosed with adult growth hormone deficiency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to growth hormone or its ingredients.
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I have a psychiatric condition that significantly affects my daily life.
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I have a neurological condition that significantly affects my daily life, excluding traumatic brain injury.
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My BMI is over 35 or my weight exceeds 350 lbs.
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I do not have any active infections, cancer, or severe chronic illnesses like uncontrolled diabetes, heart failure, or COPD.
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I am not pregnant or can use barrier contraceptives if of child-bearing potential.
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I am currently using growth hormone, estrogen, certain supplements, contraceptives, or high-dose steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in truncal fat mass from baseline to six months
Secondary study objectives
Assessment of quality of life
Cardiometabolic Risk Factors
Depression, Anxiety, and Stress
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Growth Hormone Replacement TherapyExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant human growth hormone
2003
Completed Phase 4
~210

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Growth Hormone Replacement Therapy (GHRT) works by stimulating growth, cell reproduction, and cell regeneration, which can be particularly beneficial for Gulf War Syndrome (GWS) patients. These patients often experience symptoms like fatigue, muscle weakness, and cognitive dysfunction. By promoting cellular repair and regeneration, GHRT can help alleviate these symptoms and improve overall quality of life. Additionally, GHRT may reduce fat accumulation, addressing another common issue in GWS patients. Understanding these mechanisms is essential for developing effective treatment plans tailored to the needs of GWS patients.
Psychological aspects of the Canadian randomized controlled trial of human growth hormone and low-dose ethinyl oestradiol in children with Turner syndrome. The Canadian Growth Hormone Advisory Group.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,021 Previous Clinical Trials
6,030,205 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
81 Patients Enrolled for Gulf War Syndrome
United States Department of DefenseFED
901 Previous Clinical Trials
332,935 Total Patients Enrolled
7 Trials studying Gulf War Syndrome
607 Patients Enrolled for Gulf War Syndrome
Ricardo Jorge, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Recombinant human growth hormone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05355272 — Phase 2
Gulf War Syndrome Research Study Groups: Growth Hormone Replacement Therapy
Gulf War Syndrome Clinical Trial 2023: Recombinant human growth hormone Highlights & Side Effects. Trial Name: NCT05355272 — Phase 2
Recombinant human growth hormone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355272 — Phase 2
~9 spots leftby May 2025