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

Purpose

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).

Conditions

  • Adult Growth Hormone Deficiency
  • Mild Traumatic Brain Injury

Eligibility

Eligible Ages
Between 21 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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. Age 21 - 55 years old 4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey. 5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline 6. Score of 11 or more on QoL-AGHDA 7. 4-week stability on any psychotropic medications 8. 3-month stability on all other hormone treatments 9. Able and willing to provide informed consent to participate in this study, and complete study protocol.

Exclusion Criteria

  1. History of moderate or severe TBI 2. History of neurologic disorder other than TBI 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 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. BMI > 40 or body weight > 350 lbs 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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two arm study: active drug vs placebo
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Growth Hormone Replacement Therapy 		Recombinant Human Growth Hormone
  • Drug: Somatropin
    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.
Placebo Comparator
Placebo 		Placebo
  • Other: Placebo
    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.

Recruiting Locations

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota 55417-2309
Contact:
Shalamar Sibley, MD
612-725-2000
Shalamar.Sibley@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030-4211
Contact:
Sanjay Mediwala, MD
713-791-1414
Sanjay.Mediwala@va.gov

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington 98108-1532
Contact:
Megan M Herodes, BS
206-764-2984
Megan.Herodes@va.gov

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Deane V Walker, MHA BS AB
(203) 937-3440
Deane.Walker@va.gov