What side effects are associated with this type of intervention?

Growth Hormone Replacement Therapy (GHRT), used to treat conditions like Gulf War Syndrome, can have several side effects. Commonly reported adverse events include peripheral edema, injection site problems, and an increased frequency of musculoskeletal abnormalities such as kyphoscoliosis and slipped epiphysis. Additionally, there is a potential risk of tumor recurrence in patients with a history of cancer, although this risk is not significantly higher than in those not treated with GH. Other side effects may include joint pain, muscle pain, and carpal tunnel syndrome.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Gulf War Syndrome that focus on growth hormone replacement therapy. However, growth hormone replacement therapy is being studied for its potential benefits in reducing fat and alleviating symptoms in veterans with Gulf War Illness and adult growth hormone deficiency. This therapy aims to stimulate growth, cell reproduction, and cell regeneration, which may offer symptomatic relief for affected individuals.

What other types of research exist?

Promising novel alternatives to Growth Hormone Replacement Therapy for Gulf War Syndrome patients may include: 1) C-type Natriuretic Peptide (CNP) analogues, which have shown potential in promoting bone growth and could be beneficial for overall health. 2) Soluble FGFR3 therapy, which has demonstrated efficacy in restoring bone growth in animal models and may offer similar benefits in humans. These alternatives target pathways involved in growth and regeneration, potentially offering benefits similar to GHRT.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

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.