Growth Hormone Replacement Therapy for Retried Professional Football Players

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Биопрепарат 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
• Другое Placebo
  Daily self-injections by subjects: 1-year double-blind phase

Первичные конечные точки

• Cognitive functions- Working Memory [Срок оценки: From baseline to 1-year post-treatment]
• Cognitive functions- Processing Speed [Срок оценки: From baseline to 1-year post-treatment]
• Cognitive functions- Executive Function. [Срок оценки: From baseline to 1-year post-treatment]
• Cognitive functions- Verbal learning and memory [Срок оценки: From baseline to 1-year post-treatment]
• Cognitive functions- ANAM ( Automated Psychological Assessment Metrics) [Срок оценки: From baseline to 1-year post-treatment]

Вторичные конечные точки (9)

• Quality of Life Assessment of Growth Hormone Deficiency in Adults [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in QEEG Markers- power spectra [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in QEEG Markers- Connectivity Measures [Срок оценки: One year (from baseline to 1-year post-treatment)]
• MRI [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in Physical function- Peak O2 consumption (Vo2 max) [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in Physical function- Maximum grip strength [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in Physical function- Isokinetic knee extension peak torque [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Change in Physical function-DEXA measure [Срок оценки: One year (from baseline to 1-year post-treatment)]
• Adverse events [Срок оценки: One year (from baseline to 1-year post-treatment)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Center for Neurolgoical Studies (CNS) — Dearborn

Публикации

• 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

Идентификаторы

NCT: NCT04121780 · UTN: U1111-1201-5972

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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