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

Phase 3

Not yet recruiting

• Conditions: Adult Growth Hormone Deficiency; Mild Traumatic Brain Injury
• Interventions: Drug: Somatropin; Other: Placebo

• Registration Number: NCT04867317
• Lead Sponsor: VA Office of Research and Development

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Start: 2025-01-20
• Primary Completion: 2026-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• OEF/OIF/OND Veteran
• Score of 1 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
• Age 21 - 55 years old
• One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey
• GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
• Score of 11 or more on QoL-AGHDA
• 4-week stability on any psychotropic medications
• 3-month stability on all other hormone treatments
• Able and willing to provide informed consent to participate in this study, and complete study protocol.

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Exclusion Criteria

• History of moderate or severe TBI
• History of neurologic disorder other than TBI with substantial impact on quality of life
• History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
• 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
• Contraindication to rhGH therapy
• Contraindication to macimorelin use, including QTc interval >450ms (male) or >470ms (female)
• Acute medical illness, active infection, cancer or decompensated chronic medical illness
• 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.
• Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory Malingering (TOMM).
• BMI > 35 or body weight > 350 lbs
• 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)
• Women who are pregnant or of child-bearing potential not on contraception
• Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
• 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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth Hormone Replacement Therapy	Somatropin	Recombinant Human Growth Hormone
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)	6 months	25 question survey on quality of life; The primary objective of CSP #2018 is to determine the efficacy of rhGH, given daily for 6 months, versus placebo to improve QoL, as measured by difference in mean QoL-AGHDA score, among Veterans with a history of mTBI and AGHD (primary outcome). The primary hypothesis is that the investigators, compared to placebo, patients treated with rhGH will exhibit a 3.5-point lower mean score (higher quality of life) in QoL-AGHDA at 6 months. QoL-AGHDA: minimum score=0 (high QoL: best outcome); maximum score=25 (low QoL: worst outcome).

Secondary Outcome Measures

Name	Time	Method
Body Composition	6 months	DEXA (Dual-Energy x-ray absorptiometry); The secondary objective of CSP #2018 is to investigate the efficacy of rhGH vs placebo on long-term surrogate outcomes: a) body composition, assessed through dual-energy x-ray absorptiometry (DEXA) and b) cardiometabolic risk factors including lipids, autonomic function, and highly sensitive C-reactive protein. The specific hypotheses for these outcomes are that compared to placebo there will be a 4.5% mean reduction in total truncal body fat percentage and a mean reduction of 10 mg/dL in LDL serum levels after 6 months of treatment and follow-up of rhGH.

Trial Locations

Locations (5)

Miami VA Healthcare System, Miami, FL; 🇺🇸 Miami, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur, GA; 🇺🇸 Decatur, Georgia, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States