NCT04121780

Growth Hormone Replacement Therapy for Retried Professional Football Players

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Center for Neurological Studies · Academic / Other
• Sex: Male
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-08
• Primary completion: 2025-03-01
• Completion: 2026-09-01
• First posted: 2019-10-10
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study