Growth hormone therapy for veterans with mild brain injuries and hormone deficiency
CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
This study is testing if growth hormone therapy can help improve the quality of life for veterans with mild brain injuries and hormone deficiency.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (Decatur, Georgia and 3 other locations) |
| Trial ID | NCT04867317 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of growth hormone replacement therapy (GHRT) compared to a placebo in improving the quality of life for veterans diagnosed with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI). Participants will include veterans aged 21 to 55 who have experienced one or more mild TBIs during military service and have been diagnosed with GH deficiency. The study will involve administering somatropin or a placebo and assessing the outcomes over a specified period. The goal is to determine if GHRT can provide significant benefits in quality of life for this population.
Who should consider this trial
Good fit: Ideal candidates are OEF/OIF/OND veterans aged 21-55 with a diagnosis of AGHD and a history of mild TBI.
Not a fit: Patients with moderate or severe TBI or significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance the quality of life for veterans suffering from AGHD and mTBI.
How similar studies have performed: Other studies have shown promise in using growth hormone therapy for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Decatur, Georgia and 3 other locations
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Recruiting)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Deane V Walker, MHA BS AB
- Email: Deane.Walker@va.gov
- Phone: (203) 937-3440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.