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NCT04867317PHASE3Recruiting

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

VA Office of Research and Development

Start Date

1/13/2025

Completion Date

9/30/2029

Summary

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).

Eligibility Criteria

Age Range: 21 years to 55 years

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)

Interventions

DRUG

Somatropin

OTHER

Placebo

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Conditions

Adult Growth Hormone DeficiencyMild Traumatic Brain Injury

Locations

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama 35233-1927

United States

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona 85012

United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California 92161-0002

United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado 80045-7211

United States

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia 20422-0001

United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia 30033-4004

United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan 48105-2303

United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota 55417-2309

United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri 64128-2226

United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska 68105-1850

United States

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina 28144

United States

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma 73104-5007

United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas 75216-7167

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas 77030-4211

United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas 78229-4404

United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington 98108-1532

United States