Growth Hormone Replacement Therapy for Retried Professional Football Players

Center for Neurological Studies

Status and phase: Enrolling; Phase 2

Conditions: Sport Injury; Anterior Pituitary Hyposecretion Syndrome; Concussion, Brain; Growth Hormone Deficiency; Hypopituitarism; TBI (Traumatic Brain Injury)

Treatments: Other: Placebo; Biological: Growth Hormone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04121780

UTN: U1111-1201-5972

Details and patient eligibility

About

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).

Full 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.

Enrollment: 42 estimated patients

Sex: Male

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Growth Hormone

Experimental group

Description:

Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).

Treatment:

Biological: Growth Hormone

Saline

Placebo Comparator group

Description:

Saline-placebo via auto-injector pens (Haselmeier Inc).

Treatment:

Other: Placebo