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

RecruitingPhase 3Ages 21 Years - 55 YearsAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • Somatropin
  • Placebo
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Where

16 sites
Birmingham VA Medical Center, Birmingham, AL
Birmingham, United States
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, United States
VA San Diego Healthcare System, San Diego, CA
San Diego, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, United States

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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