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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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)

• 4-week stability on any psychotropic medications

• 3-month stability on all hormone treatments

• able and willing to provide informed consent to participant in the study and complete study protocol

Locations
United States
Texas
Michael E. DeBakey VA Medical Center
RECRUITING
Houston
Washington
VA Puget Sound Healthcare System
RECRUITING
Seattle
Contact Information
Primary
Dakota Broadway, MS
dakota.broadway@bcm.edu
(281) 896-0787
Backup
Audri Villalon
audri.villalon@bcm.edu
(281) 896-0787
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2026-07
Participants
Target number of participants: 20
Treatments
Experimental: Growth Hormone Replacement Therapy
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).
Sponsors
Collaborators: United States Department of Defense
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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