Growth Hormone Replacement Therapy for Retried Professional Football Players

  • End date
    Sep 6, 2024
  • participants needed
  • sponsor
    Center for Neurological Studies
Updated on 6 August 2021
growth hormone


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).


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.

Condition Growth Hormone Deficiency, Sport Injury, Traumatic Brain Injury, Total Body Irradiation, Concussion, total-body irradiation, GH deficiency, Pituitary Disorders, Hypopituitarism, Pituitary Disease, traumatic brain injury (tbi), Brain Injury
Treatment Placebo, Growth hormone
Clinical Study IdentifierNCT04121780
SponsorCenter for Neurological Studies
Last Modified on6 August 2021


Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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