Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBaylor College of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91
age less than or equal to 64 years old
have a diagnosis of Gulf War Illness assessed by study investigators
have adult growth hormone deficiency diagnosed by glucagon stimulation test (cut point 3.0 mcg/L if BMI is less than or equal to 25 or 1.0 mcg/L if BMI is greater than 25)
Disqualifiers
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)
history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life
other known cause for growth hormone deficiency (GHD) including history of childhood onset GHD, hypothalamic/pituitary disease, history of brain radiation, or genetic mutations known to lead to GHD
active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale
Trial design
Design model
Single group
Treatments tested in this trial
Recombinant human growth hormone
Drugrecombinant human growth hormone (rhGH)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Growth Hormone Replacement TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in truncal fat mass from baseline to six months
The primary outcome measure is the difference of truncal fat mass percentage from baseline to six months. Truncal fat mass will be assessed at baseline, 3-months, and 6-months using calibrated dual energy x-ray absorptiometry (DEXA). A large mean difference corresponds with greater changes in truncal fat mass. Decreased truncal fat mass is associated with reduced risk of cardiovascular disease.
Time frame
6 monthsSecondary outcomes
1
Cardiometabolic Risk Factors
Change in cardiometabolic risk factors from baseline to 6 months measured by fasting low density lipoproteins (LDL) and highly sensitive C-reactive protein levels. A decrease in lipoprotein corresponds with increased lipoprotein metabolism, and lower C-reactive protein levels corresponds with less inflammation. A reduction in both suggests lower risk of cardiometabolic disease.
Time frame
6 months2
Lean body mass
The change in appendicular lean body mass between baseline and 6 months will be assessed using calibrated dual energy x-ray absorptiometry. The difference will capture changes in body composition (fat and muscle) with a higher difference corresponding with greater body composition changes.
Time frame
6 months3
Assessment of quality of life
Change in the quality of life from baseline to 6 months will be measured by the Quality of Life questionnaire for Adult Growth Hormone Deficiency. The score ranges from 0 to 25, with a score of 25 representing highest symptomatic burden and lower quality of life. A change in score is positively correlated with the patient's perception of treatment benefit, and a score change of 3.5 points is considered clinically meaningful.
Time frame
6 months4
Fatigue
Fatigue will be measured using the Fatigue Severity Scale. The questionnaire minimum score is a 9 and maximum score is 63. Higher scores represent greater fatigue severity.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor College of Medicine
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov