Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
VA Office of Research and Development
172 participants
Jan 13, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).
Eligibility
Inclusion Criteria9
- OEF/OIF/OND Veteran
- Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
- Age 21 - 55 years old
- One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey
- GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
- Score of 11 or more on QoL-AGHDA
- week stability on any psychotropic medications
- month stability on all other hormone treatments
- Able and willing to provide informed consent to participate in this study, and complete study protocol.
Exclusion Criteria14
- History of moderate or severe TBI
- History of neurologic disorder other than TBI with substantial impact on quality of life
- History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
- Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months
- Contraindication to rhGH therapy
- Contraindication to macimorelin use, including QTc interval \>470ms
- Acute medical illness, active infection, cancer or decompensated chronic medical illness
- Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
- Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory Malingering (TOMM).
- BMI \> 35 or body weight \> 350 lbs
- Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
- Women who are pregnant or of child-bearing potential not on contraception
- Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
- Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
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Interventions
Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT04867317