Growth hormone therapy for veterans with mild brain injuries and hormone deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. OEF/OIF/OND Veteran
2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
3. One or more mild traumatic brain injury (mTBI) sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
4. Growth hormone (GH) deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 micrograms per liter), or glucagon stimulation test (cut point: 3 micrograms per liter (mcg/L) for body mass index up to 25; cut point 1 micrograms per liter for body mass index (BMI) 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
5. Score of 11 or more on QoL-AGHDA
6. 4-week stability on any psychotropic medications
7. 3-month stability on all other hormone treatments
8. Able and willing to provide informed consent to participate in this study, and complete study protocol

Exclusion Criteria:

1. History of moderate or severe traumatic brain injury (TBI)
2. History of neurologic disorder other than traumatic brain injury with substantial impact on quality of life
3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
4. 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.
5. Contraindication to recombinant human growth hormone (rhGH) therapy
6. Acute medical illness, active infection, cancer or decompensated chronic medical illness
7. 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.
8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).
9. body mass index (BMI) \> 40 or body weight \> 350 pounds
10. 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)
11. Women who are pregnant or of child-bearing potential not on contraception
12. Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
13. Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)

Where it's running

• Rocky Mountain Regional VA Medical Center, Aurora, CO
  Aurora, Colorado, United States Recruiting
• VA Ann Arbor Healthcare System, Ann Arbor, MI
  Ann Arbor, Michigan, 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
• Birmingham VA Medical Center, Birmingham, AL
  Birmingham, Alabama, United States Not yet recruiting

Study contacts

• Study coordinator: Deane V Walker, MHA BS AB
• Email: Deane.Walker@va.gov
• Phone: (203) 937-3440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.