RecruitingPhase 3NCT04867317

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

CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)


Sponsor

VA Office of Research and Development

Enrollment

172 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether growth hormone replacement therapy can improve quality of life, cognitive function, and other outcomes in veterans who sustained a mild traumatic brain injury (mTBI) during military service and now have adult growth hormone deficiency (AGHD). Brain injuries can damage the pituitary gland — the brain's hormone control center — leading to growth hormone deficiency that causes fatigue, cognitive difficulties, reduced quality of life, and other symptoms. Replacing growth hormone in this population may help address these lasting effects of combat injury. Veterans of OEF/OIF/OND who have both confirmed mTBI (from service) and growth hormone deficiency will be randomly assigned to receive recombinant human growth hormone (rhGH) or placebo. Outcomes including quality of life, cognitive performance, mood, and physical function will be tracked over time. You may be eligible if: - You are an OEF/OIF/OND veteran, aged 21–55 - You sustained one or more mTBIs during military service at least 12 months ago - You have confirmed growth hormone deficiency (by macimorelin test and IGF-I level) - Your quality of life is significantly impacted (QoL-AGHDA score ≥11) - Your medications and hormones have been stable for at least 3–4 weeks You may NOT be eligible if: - You have a history of moderate or severe TBI - You have bipolar disorder, schizophrenia, or active suicidal ideation - You have active cancer, severe infection, or other serious illness - Your BMI is above 35 or you weigh more than 350 lbs - You are a woman of childbearing potential not using contraception - You are currently using growth hormone or related hormones Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSomatropin

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.

OTHERPlacebo

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.


Locations(17)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, United States

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, United States

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

Omaha, Nebraska, United States

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

Salisbury, North Carolina, United States

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, United States

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

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

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

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04867317


Related Trials