RECRUITING

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

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Conditions

Gulf War SyndromeAdult Growth Hormone Deficiencyrecombinant human growth hormonegrowth hormone replacement therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-12
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05355272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91
  2. 2. age less than or equal to 64 years old
  3. 3. have a diagnosis of Gulf War Illness assessed by study investigators
  4. 4. 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)
  5. 5. 4-week stability on any psychotropic medications
  6. 6. 3-month stability on all hormone treatments
  7. 7. able and willing to provide informed consent to participant in the study and complete study protocol
  1. 1. 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)
  2. 2. history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life
  3. 3. 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
  4. 4. active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale
  5. 5. suicidal behavior in the past 6 months
  6. 6. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product
  7. 7. acute medical illness, active infection, cancer, or decompensated chronic medical illness (e.g., decompensated diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease)
  8. 8. evidence of substance use disorder in the past 6 months other than mild alcohol or cannabis use disorder diagnosed by clinician at time of screening.
  9. 9. urine toxicology evidence of illicit drug use (excluding cannabis) within the past 90 days prior to screening
  10. 10. BMI \> 35 or body weight \> 350 lbs
  11. 11. abnormal pituitary anatomy documented by an MRI using a Sella protocol
  12. 12. women who are pregnant or of child-bearing potential who are unable/unwilling to use one of the following barrier contraceptives: condoms, diaphragm, cervical cap, or intrauterine device
  13. 13. current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, hormonal contraceptives, progestin, insulin growth factor 1 (IGF-1), or chronic glucocorticoid use in supraphysiologic doses

Contacts and Locations

Study Contact

Dakota Broadway, MS
CONTACT
(281) 896-0787
dakota.broadway@bcm.edu
Audri Villalon
CONTACT
(281) 896-0787
audri.villalon@bcm.edu

Principal Investigator

Ricardo Jorge, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Ricardo Jorge, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • recombinant human growth hormone
  • growth hormone replacement therapy

Additional Relevant MeSH Terms

  • Gulf War Syndrome
  • Adult Growth Hormone Deficiency