Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Apr 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether growth hormone replacement therapy (GHRT) can improve the quality of life for veterans who have both mild traumatic brain injury (mTBI) and adult growth hormone deficiency (AGHD). The researchers want to see if GHRT is more effective than a placebo (a treatment with no active ingredients) in helping these veterans feel better overall.

To participate in this study, you must be a veteran aged 21 to 55 who has experienced at least one mild traumatic brain injury during military service and has been diagnosed with growth hormone deficiency. You also need to have a score indicating a low quality of life and be stable on any medications you're taking. Participants will receive either the growth hormone treatment or a placebo and will be monitored throughout the study to see how they respond. It’s important to know that certain medical conditions and medications might exclude you from joining, so discussing your eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 4-week stability on any psychotropic medications
• • 3-month stability on all other hormone treatments
• • Able and willing to provide informed consent to participate in this study, and complete study protocol.
• Exclusion Criteria:
• • 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)