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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
GWIT Trial Summary
This trial is testing if growth hormone replacement therapy can help veterans with Gulf War Illness and growth hormone deficiency by reducing the percentage of fat mass in their trunk. The study will also look at if a bigger trial testing this therapy would be possible.
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.Check my eligibility
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.See study design
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.
GWIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 64 years old or younger.
Select...
I have been diagnosed with Gulf War Illness by the study's doctors.
Select...
I have been diagnosed with adult growth hormone deficiency.
GWIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in truncal fat mass from baseline to six months
Secondary outcome measures
Assessment of quality of life
Cardiometabolic Risk Factors
Depression, Anxiety, and Stress
+3 moreGWIT 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
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,392 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
81 Patients Enrolled for Gulf War Syndrome
United States Department of DefenseFED
865 Previous Clinical Trials
327,679 Total Patients Enrolled
6 Trials studying Gulf War Syndrome
415 Patients Enrolled for Gulf War Syndrome
Ricardo Jorge, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to growth hormone or its ingredients.I have a psychiatric condition that significantly affects my daily life.I am 64 years old or younger.I have a neurological condition that significantly affects my daily life, excluding traumatic brain injury.My BMI is over 35 or my weight exceeds 350 lbs.I do not have any active infections, cancer, or severe chronic illnesses like uncontrolled diabetes, heart failure, or COPD.I have been on the same hormone treatment for at least 3 months.You have a growth hormone deficiency diagnosed by a glucagon stimulation test with specific cut-off levels based on your body mass index (BMI).I am not pregnant or can use barrier contraceptives if of child-bearing potential.I have a known reason for my growth hormone deficiency, such as a genetic condition or previous brain treatment.My mental health medication has been stable for at least 4 weeks.I am currently using growth hormone, estrogen, certain supplements, contraceptives, or high-dose steroids.I have been diagnosed with Gulf War Illness by the study's doctors.I have been diagnosed with adult growth hormone deficiency.I have been diagnosed with Gulf War Illness by the study's doctors.You served in the military during the Gulf War in 1990-91.I am 64 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Growth Hormone Replacement Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this medical research that individuals can join?
"Information on clinicaltrials.gov reveals that this medical trial has ceased its search for participants, as the study was initially posted August 1st 2022 and last updated April 26th 2022. However, 25 other studies are currently seeking enrolment at this time."
Answered by AI
Is this investigation accepting participants that are thirty years or older?
"This clinical trial is open to participants between 18 and 64 years old. Additionally, there are 15 trials for minors and 10 trials specifically targeted at seniors aged 65 or over."
Answered by AI
Is there an opportunity to participate in this clinical research?
"To be eligible for this clinical trial, participants must have been diagnosed with Gulf War Syndrome and lie within the age brackets of 18 to 64 years old. A total of 36 people are being admitted into this study."
Answered by AI
Has the FDA sanctioned Recombinant human growth hormone for medicinal applications?
"The safety of Recombinant human growth hormone was assessed at a 2 because the Phase 2 trial has not yet revealed conclusive efficacy data, but there is some evidence for its safe usage."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Michael E. DeBakey VA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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