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Recruiting NCT04121780

Growth Hormone Replacement Therapy for Retried Professional Football Players

Phase II Interventional TBI (Traumatic Brain Injury) Concussion, Brain Sport Injury Anterior Pituitary Hyposecretion Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Growth Hormone, Placebo.
Who it may be relevant to
Registry conditions: TBI (Traumatic Brain Injury), Concussion, Brain, Sport Injury, Anterior Pituitary Hyposecretion Syndrome. Basic parameters: 18 years — 76 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency

Overview

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

Detailed description

GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.

Interventions

  • Biological Growth Hormone
    Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
  • Other Placebo
    Daily self-injections by subjects: 1-year double-blind phase

Primary outcome measures

  • Cognitive functions- Working Memory [Time frame: From baseline to 1-year post-treatment]
  • Cognitive functions- Processing Speed [Time frame: From baseline to 1-year post-treatment]
  • Cognitive functions- Executive Function. [Time frame: From baseline to 1-year post-treatment]
  • Cognitive functions- Verbal learning and memory [Time frame: From baseline to 1-year post-treatment]
  • Cognitive functions- ANAM ( Automated Psychological Assessment Metrics) [Time frame: From baseline to 1-year post-treatment]
Secondary outcome measures (9)
  • Quality of Life Assessment of Growth Hormone Deficiency in Adults [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in QEEG Markers- power spectra [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in QEEG Markers- Connectivity Measures [Time frame: One year (from baseline to 1-year post-treatment)]
  • MRI [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in Physical function- Peak O2 consumption (Vo2 max) [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in Physical function- Maximum grip strength [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in Physical function- Isokinetic knee extension peak torque [Time frame: One year (from baseline to 1-year post-treatment)]
  • Change in Physical function-DEXA measure [Time frame: One year (from baseline to 1-year post-treatment)]
  • Adverse events [Time frame: One year (from baseline to 1-year post-treatment)]

Eligibility criteria

Inclusion criteria

  • The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.
  • Former NFL player
  • At least one year since retirement from football
  • Less than 76 years of age
  • Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD

Exclusion criteria

  • History of pre-existing brain disease other than concussion or TBI
  • History of a premorbid disabling condition that interferes with outcome assessments
  • Contraindication to GH therapy
  • Type I and II Diabetes mellitus
  • Active malignant disease
  • Acute critical illness, heart failure, or acute respiratory failure
  • Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center for Neurolgoical Studies (CNS) — Dearborn

Publications

  • Benson RR, Gattu R, Sewick B, Kou Z, Zakariah N, Cavanaugh JM, Haacke EM. Detection of hemorrhagic and axonal pathology in mild traumatic brain injury using advanced MRI: implications for neurorehabilitation. NeuroRehabilitation. 2012;31(3):261-79. doi: 10.3233/NRE-2012-0795. PMID 23093454
  • Benson RR, Meda SA, Vasudevan S, Kou Z, Govindarajan KA, Hanks RA, Millis SR, Makki M, Latif Z, Coplin W, Meythaler J, Haacke EM. Global white matter analysis of diffusion tensor images is predictive of injury severity in traumatic brain injury. J Neurotrauma. 2007 Mar;24(3):446-59. doi: 10.1089/neu.2006.0153. PMID 17402851
  • Falleti MG, Maruff P, Burman P, Harris A. The effects of growth hormone (GH) deficiency and GH replacement on cognitive performance in adults: a meta-analysis of the current literature. Psychoneuroendocrinology. 2006 Jul;31(6):681-91. doi: 10.1016/j.psyneuen.2006.01.005. Epub 2006 Apr 18. PMID 16621325
  • Deijen JB, de Boer H, Blok GJ, van der Veen EA. Cognitive impairments and mood disturbances in growth hormone deficient men. Psychoneuroendocrinology. 1996 Apr;21(3):313-22. doi: 10.1016/0306-4530(95)00050-x. PMID 8817729
  • Deijen JB, de Boer H, van der Veen EA. Cognitive changes during growth hormone replacement in adult men. Psychoneuroendocrinology. 1998 Jan;23(1):45-55. doi: 10.1016/s0306-4530(97)00092-9. PMID 9618751
  • Kelestimur F, Tanriverdi F, Atmaca H, Unluhizarci K, Selcuklu A, Casanueva FF. Boxing as a sport activity associated with isolated GH deficiency. J Endocrinol Invest. 2004 Dec;27(11):RC28-32. doi: 10.1007/BF03345299. PMID 15754728
  • Kelly DF, Chaloner C, Evans D, Mathews A, Cohan P, Wang C, Swerdloff R, Sim MS, Lee J, Wright MJ, Kernan C, Barkhoudarian G, Yuen KC, Guskiewicz K. Prevalence of pituitary hormone dysfunction, metabolic syndrome, and impaired quality of life in retired professional football players: a prospective study. J Neurotrauma. 2014 Jul 1;31(13):1161-71. doi: 10.1089/neu.2013.3212. Epub 2014 May 8. PMID 24552537
  • High WM Jr, Briones-Galang M, Clark JA, Gilkison C, Mossberg KA, Zgaljardic DJ, Masel BE, Urban RJ. Effect of growth hormone replacement therapy on cognition after traumatic brain injury. J Neurotrauma. 2010 Sep;27(9):1565-75. doi: 10.1089/neu.2009.1253. PMID 20578825

Identifiers

NCT: NCT04121780 · UTN: U1111-1201-5972

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗